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Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.
This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 440 mg naproxen sodium with 1000 mg acetaminophen | Experimental | 440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets |
|
| 220 mg naproxen sodium with 650 mg acetaminophen | Experimental | 220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet |
|
| 10 mg hydrocodone + 650 mg acetaminophen | Active Comparator | 10 mg hydrocodone + 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets |
|
| 440 mg naproxen sodium | Active Comparator | 440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets |
|
| Placebo tablet | Placebo Comparator | Single dose of four placebo tablets |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 440 mg naproxen sodium with 1000 mg acetaminophen | Drug | 440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 6 hours. | Baseline (0 hour) up to 6 hours post-dose |
| Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 12 hours. | Baseline (0 hour) up to 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 60. Higher scores was indicative of more pain relief. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch, MD | Jean Brown Research (JBR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research Clinical Research | Salt Lake City | Utah | 84107 | United States |
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Placebo | Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1). |
| FG001 | Arm 2: Naproxen Sodium 440 mg | Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2019 | Nov 9, 2022 |
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Post-operative dental pain following third molar extraction.
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|
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| 220 mg naproxen sodium with 650 mg acetaminophen | Drug | 220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet |
|
|
| 10 mg hydrocodone + 650 mg acetaminophen | Drug | 10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets |
|
|
| 440 mg naproxen sodium | Drug | 440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets |
|
|
| Placebo tablet | Drug | Single dose of four placebo tablets |
|
| Baseline (0 hour) up to 6 hours post-dose |
| Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief. | Baseline (0 hour) up to 8 hours post-dose |
| Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores was indicative of more pain relief. | Baseline (0 hour) up to 12 hours post-dose |
| Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 8 hours. | Baseline (0 hour) up to 8 hours post-dose |
| Pain Relief (PAR) Scores at Individual Timepoints | Participants answered a question at individual time points: "how much relief do you have from your starting pain?" on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain. | 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours |
| Pain Intensity Difference (PID) Scores at Individual Time Points | Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration. | 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours |
| Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome. | Up to 12 hours |
| FG002 | Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1). |
| FG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| FG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Placebo | Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1). |
| BG001 | Arm 2: Naproxen Sodium 440 mg | Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
| BG002 | Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1). |
| BG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| BG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 6 hours. | Intent-to-Treat (ITT) analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (0 hour) up to 6 hours post-dose |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 12 hours. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (0 hour) up to 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 60. Higher scores was indicative of more pain relief. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (0 hour) up to 6 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (0 hour) up to 8 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores was indicative of more pain relief. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (0 hour) up to 12 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 8 hours. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (0 hour) up to 8 hours post-dose |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Pain Relief (PAR) Scores at Individual Timepoints | Participants answered a question at individual time points: "how much relief do you have from your starting pain?" on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Pain Intensity Difference (PID) Scores at Individual Time Points | Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration. | ITT analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Units on a scale | 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome. | ITT analysis set included all randomized participants. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Up to 12 hours |
|
Up to Day 10
The safety analysis set included all participants who were randomized and took investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Placebo | Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1). | 0 | 35 | 0 | 35 | 14 | 35 |
| EG001 | Arm 2: Naproxen Sodium 440 mg | Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). | 0 | 69 | 0 | 69 | 5 | 69 |
| EG002 | Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1). | 0 | 61 | 0 | 61 | 8 | 61 |
| EG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). | 0 | 63 | 0 | 63 | 9 | 63 |
| EG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). | 0 | 62 | 0 | 62 | 22 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Alveolar osteitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 21.0 | Systematic Assessment |
|
Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ASSOCIATE DIRECTOR CLINICAL RESEARCH | Johnson & Johnson Consumer, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2019 | Nov 9, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D000082 | Acetaminophen |
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1). |
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
|
|
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
|
|
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
|
|
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
|
|
Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1). |
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
|
|
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
|
|
| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
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| OG003 | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). |
| OG004 | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). |
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