Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.
This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232, administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after molar extractions. Subjects will stay at the research center for ~24 hours after administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical history, vital signs, an electrocardiogram (ECG), and clinical laboratory tests. Eligible subjects will return to the clinic on the day of surgery and complete baseline vital signs and clinical laboratory tests. They will undergo dental extraction of a minimum of three third-molars and, if qualified, will be randomly assigned to one of four study treatments for pain.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-10450232 250 mg | Experimental |
| |
| JNJ-10450232 1000 mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Acetaminophen 1000 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-10450232 / Not yet marketed | Drug | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6) | Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). | 6 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 15 minutes post dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Derek Muse, MD | Jean Brown Research | Principal Investigator |
| Cathy Gelotte, Ph.D. | McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37625518 | Derived | Gelotte CK, Vakil AM, Zimmerman BA, Zannikos P, Mishra R, Eichenbaum G, Kuffner EK, Flores CM. JNJ-10450232 (NTM-006), A novel non-opioid with structural similarities to acetaminophen, produces relatively long-lasting analgesia after a single dose in patients undergoing 3rd molar extraction. Regul Toxicol Pharmacol. 2025 Sep;161 Suppl 1:105480. doi: 10.1016/j.yrtph.2023.105480. Epub 2023 Aug 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Three placebo capsules taken orally |
| FG001 | Acetaminophen 1000 mg | Two encapsulated 500 mg tablets and one placebo capsule taken orally |
| FG002 | JNJ-10450232 250 mg | One JNJ-10450232 250 mg capsule and two placebo capsules taken orally |
| FG003 | JNJ-10450232 1000 mg | One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Three placebo capsules taken orally |
| BG001 | Acetaminophen 1000 mg | Two encapsulated 500 mg tablets and one placebo capsule taken orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6) | Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 Hours |
|
Within 7 days after dental surgery, +30 days for serious adverse events.
Adverse events (AEs) were systematically collected during the study and during the adverse event follow-up telephone interview within 7 days after dental surgery. Serious AEs were reported through 30 days after product use. Spontaneously reported AEs collected outside of the regularly scheduled telephone interviews were also recorded. Any clinically important abnormalities or causally-related AEs events persisting were followed until resolution or until reaching a clinically stable endpoint.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Three placebo capsules taken orally |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Bilirubin Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Aquilina, MD, Senior Director, Clinical Research | McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. | (215) 273-8025 | JAquilin@its.jnj.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| JNJ-10450232 / Not yet marketed | Drug | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
|
| JNJ-10450232 / Not yet marketed | Drug | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
|
| acetaminophen / Tylenol | Drug | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
|
| Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose |
Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. |
| Baseline to 30 minutes post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 45 minutes post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 1 hour post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 1.5 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 2 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 3 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 4 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 5 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 6 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 7 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 8 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 9 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 10 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 11 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 12 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 16 hours post dose |
| Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Baseline to 24 hours post dose |
| Pain Relief (PAR) Scores at 15 Minutes Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 15 minutes post dose |
| Pain Relief (PAR) Scores at 30 Minutes Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 30 minutes post dose |
| Pain Relief (PAR) Scores at 45 Minutes Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 45 minutes post dose |
| Pain Relief (PAR) Scores at 1 Hour Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 1 hour post dose |
| Pain Relief (PAR) Scores at 1.5 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 1.5 hours post dose |
| Pain Relief (PAR) Scores at 2 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 2 hours post dose |
| Pain Relief (PAR) Scores at 3 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 3 hours post dose |
| Pain Relief (PAR) Scores at 4 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 4 hours post dose |
| Pain Relief (PAR) Scores at 5 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 5 hours post dose |
| Pain Relief (PAR) Scores at 6 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 6 hours post dose |
| Pain Relief (PAR) Scores at 7 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 7 hours post dose |
| Pain Relief (PAR) Scores at 8 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 8 hours post dose |
| Pain Relief (PAR) Scores at 9 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 9 hours post dose |
| Pain Relief (PAR) Scores at 10 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 10 hours post dose |
| Pain Relief (PAR) Scores at 11 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 11 hours post dose |
| Pain Relief (PAR) Scores at 12 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 12 hours post dose |
| Pain Relief (PAR) Scores at 16 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 16 hours post dose |
| Pain Relief (PAR) Scores at 24 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | 24 hours post dose |
| Duration of Pain Relief After Dosing (Time to Rescue Medication) | Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given. | Completed at time of the first rescue medication (hours post dose), estimated up through Day 2 |
| Subject Global Evaluation | How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent). | Completed at hour 12 or at time of the first rescue medication (hours post dose). |
| Withdrawal by Subject |
|
| BG002 | JNJ-10450232 250 mg | One JNJ-10450232 250 mg capsule and two placebo capsules taken orally |
| BG003 | JNJ-10450232 1000 mg | One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Acetaminophen 1000 mg | Two encapsulated 500 mg tablets and one placebo capsule taken orally |
| OG002 | JNJ-10450232 250 mg | One JNJ-10450232 250 mg capsule and two placebo capsules taken orally |
| OG003 | JNJ-10450232 1000 mg | One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally |
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 15 minutes post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 30 minutes post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 45 minutes post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 1 hour post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 1.5 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 2 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 3 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 4 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 5 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 6 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 7 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 8 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 9 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 10 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 11 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 12 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 16 hours post dose |
|
|
|
|
| Secondary | Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose | Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 24 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 15 Minutes Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 15 minutes post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 30 Minutes Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 30 minutes post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 45 Minutes Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 45 minutes post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 1 Hour Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 hour post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 1.5 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 1.5 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 2 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 2 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 3 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 3 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 4 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 4 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 5 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 5 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 6 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 7 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 7 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 8 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 8 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 9 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 10 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 10 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 11 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 11 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 12 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 16 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 16 hours post dose |
|
|
|
|
| Secondary | Pain Relief (PAR) Scores at 24 Hours Post Dose | Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | 24 hours post dose |
|
|
|
|
| Secondary | Duration of Pain Relief After Dosing (Time to Rescue Medication) | Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given. | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Median | 95% Confidence Interval | minutes | Completed at time of the first rescue medication (hours post dose), estimated up through Day 2 |
|
|
|
|
| Secondary | Subject Global Evaluation | How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent). | Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Posted | Number | percentage of participants | Completed at hour 12 or at time of the first rescue medication (hours post dose). |
|
|
|
|
| 0 |
| 67 |
| 3 |
| 67 |
| EG001 | Acetaminophen 1000 mg | Two encapsulated 500 mg tablets and one placebo capsule taken orally | 0 | 67 | 5 | 67 |
| EG002 | JNJ-10450232 250 mg | One JNJ-10450232 250 mg capsule and two placebo capsules taken orally | 0 | 69 | 3 | 69 |
| EG003 | JNJ-10450232 1000 mg | One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally | 0 | 66 | 5 | 66 |
Not provided
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| Aniline Compounds |
| D000588 | Amines |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.618 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.08 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.38 | 0.22 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.621 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.08 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.23 | 0.38 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.207 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.19 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.49 | 0.11 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.794 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.04 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.34 | 0.26 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.420 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.21 | Standard Error of the Mean | 0.26 | 2-Sided | 95 | -0.30 | 0.72 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.083 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.46 | Standard Error of the Mean | 0.26 | 2-Sided | 95 | -0.06 | 0.97 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.13 | Standard Error of the Mean | 0.26 | 2-Sided | 95 | -1.64 | -0.62 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.88 | Standard Error of the Mean | 0.26 | 2-Sided | 95 | -1.40 | -0.37 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.058 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.63 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -0.02 | 1.29 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.23 | Standard Error of the Mean | 0.34 | 2-Sided | 95 | 0.57 | 1.89 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.30 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -2.96 | -1.65 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.71 | Standard Error of the Mean | 0.34 | 2-Sided | 95 | -2.37 | -1.04 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.035 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.78 | Standard Error of the Mean | 0.36 | 2-Sided | 95 | 0.06 | 1.49 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.94 | Standard Error of the Mean | 0.37 | 2-Sided | 95 | 1.21 | 2.67 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.96 | Standard Error of the Mean | 0.36 | 2-Sided | 95 | -3.68 | -2.24 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.79 | Standard Error of the Mean | 0.37 | 2-Sided | 95 | -2.52 | -1.07 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.028 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.86 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | 0.09 | 1.64 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.48 | Standard Error of the Mean | 0.40 | 2-Sided | 95 | 1.70 | 3.26 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -3.12 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -3.90 | -2.35 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.51 | Standard Error of the Mean | 0.40 | 2-Sided | 95 | -2.29 | -0.73 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.021 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.02 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | 0.16 | 1.88 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.06 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | 2.19 | 3.93 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.77 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | -3.63 | -1.91 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.104 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.72 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | -1.59 | 0.15 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.041 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.98 | Standard Error of the Mean | 0.48 | 2-Sided | 95 | 0.04 | 1.92 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.14 | Standard Error of the Mean | 0.48 | 2-Sided | 95 | 2.19 | 4.09 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.15 | Standard Error of the Mean | 0.48 | 2-Sided | 95 | -3.09 | -1.21 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.973 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.02 | Standard Error of the Mean | 0.48 | 2-Sided | 95 | -0.93 | 0.97 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.079 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.89 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -0.10 | 1.88 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.27 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 2.27 | 4.27 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.99 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -2.98 | -1.00 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.440 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.39 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.61 | 1.40 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.118 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.81 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -0.21 | 1.83 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.13 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | 2.10 | 4.16 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.73 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -2.75 | -0.71 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.262 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.59 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -0.44 | 1.62 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.271 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.58 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -0.45 | 1.61 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.95 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | 1.91 | 3.99 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.011 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.34 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -2.37 | -0.32 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.052 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.03 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -0.01 | 2.07 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.310 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.53 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -0.50 | 1.56 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.80 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | 1.76 | 3.85 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.172 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.72 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -1.75 | 0.31 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.004 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.55 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | 0.51 | 2.60 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.479 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.36 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.64 | 1.35 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.85 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.85 | 3.86 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.345 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.48 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.47 | 0.52 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.01 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.01 | 3.02 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.299 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.53 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.47 | 1.54 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.72 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | 1.70 | 3.73 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.942 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.04 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.97 | 1.04 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.22 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | 1.21 | 3.24 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.335 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.49 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.51 | 1.49 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.79 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.78 | 3.80 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.946 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.03 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.03 | 0.97 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.27 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.25 | 3.28 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.292 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.54 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.46 | 1.53 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.67 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.66 | 3.68 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.971 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.02 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.02 | 0.98 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.11 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.11 | 3.12 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.531 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.32 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -0.68 | 1.31 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.53 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.53 | 3.54 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.722 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.18 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -1.17 | 0.81 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.04 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | 1.03 | 3.04 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.767 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.15 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -0.83 | 1.12 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.50 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | 1.52 | 3.49 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.557 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.29 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -1.27 | 0.68 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.06 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | 1.08 | 3.05 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.798 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.14 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | -0.94 | 1.22 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.32 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | 1.23 | 3.42 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.829 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.12 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | -1.20 | 0.96 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.06 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | 0.97 | 3.16 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.687 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.06 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.25 | 0.38 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.497 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.11 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.21 | 0.43 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.239 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.19 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.51 | 0.13 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.376 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.14 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.46 | 0.18 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.350 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.30 | Standard Error of the Mean | 0.32 | 2-Sided | 95 | -0.33 | 0.94 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.183 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.43 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -0.21 | 1.08 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.48 | Standard Error of the Mean | 0.32 | 2-Sided | 95 | -2.11 | -0.84 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.34 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -1.98 | -0.70 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.037 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.88 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | 0.05 | 1.71 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.47 | Standard Error of the Mean | 0.43 | 2-Sided | 95 | 0.63 | 2.30 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.90 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | -3.73 | -2.07 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.31 | Standard Error of the Mean | 0.43 | 2-Sided | 95 | -3.15 | -1.47 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.067 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.85 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -0.06 | 1.75 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.26 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | 1.34 | 3.17 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -3.49 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -4.40 | -2.59 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.08 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -3.00 | -1.17 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.023 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.13 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | 0.16 | 2.09 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.96 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | 1.98 | 3.93 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -3.75 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -4.71 | -2.78 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.91 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -2.89 | -0.94 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.012 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.36 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | 0.30 | 2.42 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.73 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | 2.66 | 4.81 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -3.35 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -4.41 | -2.29 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.074 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.98 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -2.05 | 0.09 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.026 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.32 | Standard Error of the Mean | 0.59 | 2-Sided | 95 | 0.16 | 2.48 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.82 | Standard Error of the Mean | 0.60 | 2-Sided | 95 | 2.64 | 4.99 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.48 | Standard Error of the Mean | 0.59 | 2-Sided | 95 | -3.64 | -1.32 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.978 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.02 | Standard Error of the Mean | 0.60 | 2-Sided | 95 | -1.16 | 1.19 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.081 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.07 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -0.13 | 2.28 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.91 | Standard Error of the Mean | 0.62 | 2-Sided | 95 | 2.69 | 5.14 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -2.32 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -3.53 | -1.11 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.407 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.52 | Standard Error of the Mean | 0.62 | 2-Sided | 95 | -0.71 | 1.74 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.170 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.88 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -0.38 | 2.14 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.60 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 2.33 | 4.87 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.002 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.95 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -3.21 | -0.69 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.235 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.77 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -0.50 | 2.04 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.355 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.60 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -0.68 | 1.87 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.36 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 2.07 | 4.65 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.021 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.50 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -2.78 | -0.23 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.056 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.26 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -0.03 | 2.55 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.547 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.39 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -0.89 | 1.68 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.16 | Standard Error of the Mean | 0.66 | 2-Sided | 95 | 1.86 | 4.46 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.214 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.81 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -2.10 | 0.47 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.003 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.96 | Standard Error of the Mean | 0.66 | 2-Sided | 95 | 0.66 | 3.26 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.729 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.22 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -1.03 | 1.47 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.21 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | 1.95 | 4.47 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.459 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.47 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -1.72 | 0.78 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.52 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | 1.26 | 3.78 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.417 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.52 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -0.74 | 1.79 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.05 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 1.77 | 4.33 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.698 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.25 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -1.02 | 1.52 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.77 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 1.49 | 4.05 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.409 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.53 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -0.73 | 1.79 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 3.12 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 1.85 | 4.39 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.834 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.13 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -1.12 | 1.39 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.73 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 1.45 | 4.00 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.448 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.49 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -0.77 | 1.74 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.98 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | 1.71 | 4.25 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.848 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.12 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -1.13 | 1.38 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.62 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | 1.35 | 3.89 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.763 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.19 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -1.07 | 1.45 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.82 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 1.55 | 4.09 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.952 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.04 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -1.30 | 1.22 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.59 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 1.31 | 3.86 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.978 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.02 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -1.25 | 1.22 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.88 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | 1.63 | 4.13 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.799 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.16 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -1.39 | 1.07 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.73 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | 1.49 | 3.98 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.869 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.11 | Standard Error of the Mean | 0.69 | 2-Sided | 95 | -1.48 | 1.25 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.52 | Standard Error of the Mean | 0.70 | 2-Sided | 95 | 1.13 | 3.90 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.851 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.13 | Standard Error of the Mean | 0.69 | 2-Sided | 95 | -1.24 | 1.50 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 2.76 | Standard Error of the Mean | 0.70 | 2-Sided | 95 | 1.38 | 4.15 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours. | Log Rank | 0.779 | The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves. | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours. | Log Rank | <0.001 | The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves. | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours. | Log Rank | 0.196 | The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves. | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours. | Log Rank | 0.006 | The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves. | No | Superiority or Other |
| Fair (1) |
|
| Good (2) |
|
| Very Good (3) |
|
| Excellent (4) |
|
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.077 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 0.4 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -0.0 | 0.8 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | 1.2 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | 0.8 | 1.6 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -1.1 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -1.6 | -0.7 | No | Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical score were factors. | 0.148 | The significance threshold level was 0.05 (two-sided). | Least Squares Mean Difference | -0.3 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -0.7 | 0.1 | No | Superiority or Other |