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| ID | Type | Description | Link |
|---|---|---|---|
| MIG | Other Identifier | Alias Study Number | |
| MIG II | Other Identifier | Alias Study Number |
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An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.
The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of ibuprofen/caffeine compared to ibuprofen alone and also to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen/Caffeine | Experimental | Ibuprofen 400 mg/ Caffeine 100 mg fixed-dose combination |
|
| Ibuprofen | Active Comparator | Ibuprofen 400 mg |
|
| Placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen/Caffeine | Drug | Ibuprofen/Caffeine fixed-dose combination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen | SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain. | From 0 to 8 hours post-dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | SPRID 0-2, SPRID 0-4, SPRID 0-6, SPRID 0-8: time-weighted sum of PRID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours respectively. PRID at each post-dose time point = PID + PRR. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on 5-point scale: 0=none, 1=a little, 2=some, 3=a lot, 4=complete; higher scores=more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on 11-point scale: range from 0=no pain to 10=worst possible pain; higher scores=worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value=greater improvement. Score range for: SPRID 0-2= -20 to 28; SPRID 0-4= -40 to 56; SPRID 0-6= -60 to 84; SPRID 0-8= -80 to 112. Higher SPRID scores=more improvement in pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs are classified according to severity in 3 categories as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). |
Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator to place the subject at increased risk including the presence or history within 2 years of screening of the following medical conditions/disorders:
Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen 400 mg + Caffeine 100 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 milligram (mg) with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| FG001 | Ibuprofen 400 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| FG002 | Placebo | Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who received the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen 400 mg + Caffeine 100 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| BG001 | Ibuprofen 400 mg |
| 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 | Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen | SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain. | Full analysis set (FAS) population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | From 0 to 8 hours post-dose on Day 1 |
Screening up to Day 17 after the last dose of study drug (approximately maximum 48 days)
Safety population.
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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 | Ibuprofen 400 mg + Caffeine 100 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Jul 13, 2016 | Feb 28, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2018 | Feb 28, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen |
| Drug |
Ibuprofen capsule |
|
| Placebo | Drug | Placebo treatment |
|
| From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 |
| Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8) | SPID 0-2, SPID 0-4, SPID 0-6, SPID 0-8: time-weighted sum of PID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: score range from 0 = no pain to 10 = worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible range: SPID 0-2 = -20 to 20; SPID 0-4 = -40 to 40; SPID 0-6 = -60 to 60; SPID 0-8 = -80 to 80. Higher SPID scores = more improvement in pain. | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 |
| Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8) | TOTPAR 0-2, TOTPAR 0-4, TOTPAR 0-6, TOTPAR 0-8: time-weighted sum of PRR scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. PRR score: at each post-dose time point participants answered to the question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Overall possible range: TOTPAR 0-2 = 0 to 8; TOTPAR 0-4 = 0 to 16; TOTPAR 0-6 = 0 to 24; TOTPAR 0-8 = 0 to 32. Higher TOTPAR scores = more improvement in pain. | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 |
| Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. At a single post-dose time point overall possible range for PRID score: -10 to 14, higher scores = more improvement in pain. | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1 |
| Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 |
| Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a single post-dose time point: -10 to 10, higher positive value = greater improvement in pain. | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 |
| Time to Onset of Achieving Meaningful Relief | When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "meaningful relief" at the moment when they first experienced meaningful relief, that is, when the relief from the pain was meaningful to them. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered). | Up to 8 hours post-dose on Day 1 |
| Time to Onset of First Perceptible Relief | When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "first perceptible relief" at the moment when they first began to feel any pain relieving effect. It was when they first felt a little/noticeable pain relief. It did not mean that they felt completely better (though they might), but when they first felt any difference in pain that they had at present. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered). | Up to 8 hours post-dose on Day 1 |
| Time to Treatment Failure | Treatment failure was defined as time to first dose of rescue medication or study discontinuation of the participants due to lack of efficacy. | Up to 8 hours post dose on Day 1 |
| Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) |
| Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. Relatedness of an AE to study drug was assessed by investigator. | Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included: heart rate, blood pressure, respiratory rate, and temperature. Normal range for the vital signs were: systolic blood pressure 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure 60 to 90 mmHg, heart rate 50 to 110 beats per minute, respiratory rate 12 to 22 breaths per minute, and oral temperature 97.0 to 99.6 Fahrenheit (F). Value for vital signs outside the normal range was consider as abnormal. Clinical significance of vital signs abnormalities was determined at the investigator's discretion. | Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) |
| Number of Participants Who Used Concomitant Medications, and Rescue Medications | Rescue medication: participants who did not experience adequate relief after the 1 hour (post study drug dose) evaluation were given tramadol hydrochloride 50 to 100 mg orally or codeine sulfate 15 to 60 mg orally, based on the discretion of the Investigator, as rescue medication. If needed, 2 additional doses of rescue medications based on the discretion of the Investigator at the study center was given. Total maximum dose of tramadol was 300 mg and of codeine sulfate was 180 mg. Concomitant medication: medication received by participant other than study medication and rescue medication. | Day 1 |
| Number of Participants Who Used Medications Prior to This Study | In this outcome measure number of participants who were using any type of medications, prior to start of the study were reported. | At Screening |
| Adverse Event |
|
Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| BG002 | Placebo | Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ibuprofen 400 mg + Caffeine 100 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 mg with caffeine 100 mg as a fixed dose combination on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
| OG001 | Ibuprofen 400 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug. |
|
|
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| Secondary | Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | SPRID 0-2, SPRID 0-4, SPRID 0-6, SPRID 0-8: time-weighted sum of PRID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours respectively. PRID at each post-dose time point = PID + PRR. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on 5-point scale: 0=none, 1=a little, 2=some, 3=a lot, 4=complete; higher scores=more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on 11-point scale: range from 0=no pain to 10=worst possible pain; higher scores=worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value=greater improvement. Score range for: SPRID 0-2= -20 to 28; SPRID 0-4= -40 to 56; SPRID 0-6= -60 to 84; SPRID 0-8= -80 to 112. Higher SPRID scores=more improvement in pain. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 |
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| Secondary | Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8) | SPID 0-2, SPID 0-4, SPID 0-6, SPID 0-8: time-weighted sum of PID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: score range from 0 = no pain to 10 = worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible range: SPID 0-2 = -20 to 20; SPID 0-4 = -40 to 40; SPID 0-6 = -60 to 60; SPID 0-8 = -80 to 80. Higher SPID scores = more improvement in pain. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 |
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| Secondary | Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8) | TOTPAR 0-2, TOTPAR 0-4, TOTPAR 0-6, TOTPAR 0-8: time-weighted sum of PRR scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. PRR score: at each post-dose time point participants answered to the question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Overall possible range: TOTPAR 0-2 = 0 to 8; TOTPAR 0-4 = 0 to 16; TOTPAR 0-6 = 0 to 24; TOTPAR 0-8 = 0 to 32. Higher TOTPAR scores = more improvement in pain. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 |
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| Secondary | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. At a single post-dose time point overall possible range for PRID score: -10 to 14, higher scores = more improvement in pain. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1 |
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| Secondary | Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 |
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| Secondary | Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a single post-dose time point: -10 to 10, higher positive value = greater improvement in pain. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 |
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| Secondary | Time to Onset of Achieving Meaningful Relief | When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "meaningful relief" at the moment when they first experienced meaningful relief, that is, when the relief from the pain was meaningful to them. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered). | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | Up to 8 hours post-dose on Day 1 |
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| Secondary | Time to Onset of First Perceptible Relief | When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "first perceptible relief" at the moment when they first began to feel any pain relieving effect. It was when they first felt a little/noticeable pain relief. It did not mean that they felt completely better (though they might), but when they first felt any difference in pain that they had at present. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered). | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | Up to 8 hours post-dose on Day 1 |
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| Secondary | Time to Treatment Failure | Treatment failure was defined as time to first dose of rescue medication or study discontinuation of the participants due to lack of efficacy. | FAS population included all randomized participants who received study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | Up to 8 hours post dose on Day 1 |
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| Other Pre-specified | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs are classified according to severity in 3 categories as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). | Safety analysis population included all participants who received the study medication. Here, "Overall Number of Participants Analyzed" were those participants who had at least 1 treatment emergent AEs. | Posted | Count of Participants | Participants | Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) |
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|
|
| Other Pre-specified | Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. Relatedness of an AE to study drug was assessed by investigator. | Safety analysis population included all participants who received the study medication. Here, "Overall Number of Participants Analyzed" were those participants who had at least 1 treatment emergent AEs. | Posted | Count of Participants | Participants | Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) |
|
|
|
| Other Pre-specified | Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included: heart rate, blood pressure, respiratory rate, and temperature. Normal range for the vital signs were: systolic blood pressure 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure 60 to 90 mmHg, heart rate 50 to 110 beats per minute, respiratory rate 12 to 22 breaths per minute, and oral temperature 97.0 to 99.6 Fahrenheit (F). Value for vital signs outside the normal range was consider as abnormal. Clinical significance of vital signs abnormalities was determined at the investigator's discretion. | Safety analysis population included all participants who received the study medication. | Posted | Count of Participants | Participants | Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) |
|
|
|
| Other Pre-specified | Number of Participants Who Used Concomitant Medications, and Rescue Medications | Rescue medication: participants who did not experience adequate relief after the 1 hour (post study drug dose) evaluation were given tramadol hydrochloride 50 to 100 mg orally or codeine sulfate 15 to 60 mg orally, based on the discretion of the Investigator, as rescue medication. If needed, 2 additional doses of rescue medications based on the discretion of the Investigator at the study center was given. Total maximum dose of tramadol was 300 mg and of codeine sulfate was 180 mg. Concomitant medication: medication received by participant other than study medication and rescue medication. | Safety analysis population included all participants who received the study medication. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Other Pre-specified | Number of Participants Who Used Medications Prior to This Study | In this outcome measure number of participants who were using any type of medications, prior to start of the study were reported. | Safety analysis population included all participants who received the study medication. | Posted | Count of Participants | Participants | At Screening |
|
|
|
| 0 |
| 161 |
| 0 |
| 161 |
| 15 |
| 161 |
| EG001 | Ibuprofen 400 mg | Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug. | 0 | 161 | 0 | 161 | 15 | 161 |
| EG002 | Placebo | Participants were randomized to receive a single oral dose of Placebo (matched to ibuprofen 400 mg with caffeine 100 mg fixed dose combination) on Day 1. Participants were followed up to 17 days after the last dose of study drug. | 0 | 52 | 0 | 52 | 8 | 52 |
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Alveolar osteitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
| D014970 |
| Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| SPRID 0-6 |
|
| SPRID 0-8 |
|
| < 0.001 |
| LS means difference |
| 11.13 |
| 2-Sided |
| 95 |
| 9.54 |
| 12.73 |
| Superiority |
| SPRID 0-2 | ANCOVA | < 0.001 | LS mean difference | 10.05 | 2-Sided | 95 | 8.45 | 11.64 | Superiority |
| SPRID 0-4 | ANCOVA | 0.177 | LS mean difference | 1.58 | 2-Sided | 95 | -0.72 | 3.87 | Superiority |
| SPRID 0-4 | ANCOVA | < 0.001 | LS mean difference | 24.04 | 2-Sided | 95 | 20.76 | 27.32 | Superiority |
| SPRID 0-4 | ANCOVA | < 0.001 | LS mean difference | 22.46 | 2-Sided | 95 | 19.18 | 25.75 | Superiority |
| SPRID 0-6 | ANCOVA | 0.201 | LS mean difference | 2.39 | 2-Sided | 95 | -1.28 | 6.06 | Superiority |
| SPRID 0-6 | ANCOVA | < 0.001 | LS mean difference | 34.30 | 2-Sided | 95 | 29.06 | 39.55 | Superiority |
| SPRID 0-6 | ANCOVA | < 0.001 | LS mean difference | 31.91 | 2-Sided | 95 | 26.67 | 37.16 | Superiority |
| SPRID 0-8 | ANCOVA | < 0.001 | LS mean difference | 40.85 | 2-Sided | 95 | 33.49 | 48.20 | Superiority |
| SPRID 0-8 | ANCOVA | < 0.001 | LS mean difference | 38.17 | 2-Sided | 95 | 30.81 | 45.52 | Superiority |
|
| SPID 0-6 |
|
| SPID 0-8 |
|
| < 0.001 |
| LS means difference |
| 7.55 |
| 2-Sided |
| 95 |
| 6.44 |
| 8.66 |
| Superiority |
| SPID 0-2 | ANCOVA | < 0.001 | LS means difference | 6.82 | 2-Sided | 95 | 5.71 | 7.93 | Superiority |
| SPID 0-4 | ANCOVA | 0.165 | LS means difference | 1.14 | 2-Sided | 95 | -0.47 | 2.74 | Superiority |
| SPID 0-4 | ANCOVA | < 0.001 | LS means difference | 16.35 | 2-Sided | 95 | 14.05 | 18.64 | Superiority |
| SPID 0-4 | ANCOVA | < 0.001 | LS means difference | 15.21 | 2-Sided | 95 | 12.91 | 17.51 | Superiority |
| SPID 0-6 | ANCOVA | 0.172 | LS means difference | 1.78 | 2-Sided | 95 | -0.78 | 4.34 | Superiority |
| SPID 0-6 | ANCOVA | < 0.001 | LS means difference | 23.37 | 2-Sided | 95 | 19.71 | 27.03 | Superiority |
| SPID 0-6 | ANCOVA | < 0.001 | LS means difference | 21.59 | 2-Sided | 95 | 17.93 | 25.25 | Superiority |
| SPID 0-8 | ANCOVA | 0.249 | LS means difference | 2.10 | 2-Sided | 95 | -1.47 | 5.67 | Superiority |
| SPID 0-8 | ANCOVA | < 0.001 | LS means difference | 27.88 | 2-Sided | 95 | 22.78 | 32.99 | Superiority |
| SPID 0-8 | ANCOVA | < 0.001 | LS means difference | 25.79 | 2-Sided | 95 | 20.68 | 30.89 | Superiority |
|
| TOTPAR 0-6 |
|
| TOTPAR 0-8 |
|
| < 0.001 |
| LS means difference |
| 3.59 |
| 2-Sided |
| 95 |
| 3.09 |
| 4.09 |
| Superiority |
| TOTPAR 0-2 | ANCOVA | < 0.001 | LS means difference | 3.23 | 2-Sided | 95 | 2.73 | 3.73 | Superiority |
| TOTPAR 0-4 | ANCOVA | 0.224 | LS means difference | 0.44 | 2-Sided | 95 | -0.27 | 1.15 | Superiority |
| TOTPAR 0-4 | ANCOVA | < 0.001 | LS means difference | 7.69 | 2-Sided | 95 | 6.68 | 8.71 | Superiority |
| TOTPAR 0-4 | ANCOVA | < 0.001 | LS means difference | 7.25 | 2-Sided | 95 | 6.23 | 8.27 | Superiority |
| TOTPAR 0-6 | ANCOVA | 0.293 | LS means difference | 0.61 | 2-Sided | 95 | -0.53 | 1.75 | Superiority |
| TOTPAR 0-6 | ANCOVA | < 0.001 | LS means difference | 10.93 | 2-Sided | 95 | 9.30 | 12.56 | Superiority |
| TOTPAR 0-6 | ANCOVA | < 0.001 | LS means difference | 10.32 | 2-Sided | 95 | 8.69 | 11.95 | Superiority |
| TOTPAR 0-8 | ANCOVA | 0.476 | LS means difference | 0.58 | 2-Sided | 95 | -1.03 | 2.19 | Superiority |
| TOTPAR 0-8 | ANCOVA | < 0.001 | LS means difference | 12.96 | 2-Sided | 95 | 10.66 | 15.26 | Superiority |
| TOTPAR 0-8 | ANCOVA | < 0.001 | LS means difference | 12.38 | 2-Sided | 95 | 10.08 | 14.68 | Superiority |
|
| 1 hour |
|
| 1.5 hour |
|
| 2 hour |
|
| 3 hour |
|
| 4 hour |
|
| 5 hour |
|
| 6 hour |
|
| 7 hour |
|
| 8 hour |
|
| 0.654 |
| LS means difference |
| 0.12 |
| 2-Sided |
| 95 |
| -0.40 |
| 0.63 |
| Superiority |
| PRID at 0.25 hour | ANCOVA | 0.670 | LS means difference | 0.11 | 2-Sided | 95 | -0.40 | 0.62 | Superiority |
| PRID at 0.5 hour | ANCOVA | 0.917 | LS means difference | -0.04 | 2-Sided | 95 | -0.70 | 0.63 | Superiority |
| PRID at 0.5 hour | ANCOVA | < 0.001 | LS means difference | 2.26 | 2-Sided | 95 | 1.31 | 3.20 | Superiority |
| PRID at 0.5 hour | ANCOVA | < 0.001 | LS means difference | 2.29 | 2-Sided | 95 | 1.35 | 3.24 | Superiority |
| PRID at 1 hour | ANCOVA | 0.039 | LS means difference | 0.73 | 2-Sided | 95 | 0.04 | 1.42 | Superiority |
| PRID at 1 hour | ANCOVA | < 0.001 | LS means difference | 6.11 | 2-Sided | 95 | 5.12 | 7.10 | Superiority |
| PRID at 1 hour | ANCOVA | < 0.001 | LS means difference | 5.38 | 2-Sided | 95 | 4.39 | 6.37 | Superiority |
| PRID at 1.5 hour | ANCOVA | 0.015 | LS means difference | 0.84 | 2-Sided | 95 | 0.16 | 1.52 | Superiority |
| PRID at 1.5 hour | ANCOVA | < 0.001 | LS means difference | 7.36 | 2-Sided | 95 | 6.39 | 8.33 | Superiority |
| PRID at 1.5 hour | ANCOVA | < 0.001 | LS means difference | 6.52 | 2-Sided | 95 | 5.55 | 7.49 | Superiority |
| PRID at 2 hour | ANCOVA | 0.071 | LS means difference | 0.62 | 2-Sided | 95 | -0.05 | 1.30 | Superiority |
| PRID at 2 hour | ANCOVA | < 0.001 | LS means difference | 7.62 | 2-Sided | 95 | 6.65 | 8.58 | Superiority |
| PRID at 2 hour | ANCOVA | < 0.001 | LS means difference | 6.99 | 2-Sided | 95 | 6.03 | 7.96 | Superiority |
| PRID at 3 hour | ANCOVA | 0.243 | LS means difference | 0.41 | 2-Sided | 95 | -0.28 | 1.09 | Superiority |
| PRID at 3 hour | ANCOVA | < 0.001 | LS means difference | 6.83 | 2-Sided | 95 | 5.85 | 7.80 | Superiority |
| PRID at 3 hour | ANCOVA | < 0.001 | LS means difference | 6.42 | 2-Sided | 95 | 5.44 | 7.40 | Superiority |
| PRID at 4 hour | ANCOVA | 0.823 | LS means difference | 0.08 | 2-Sided | 95 | -0.65 | 0.82 | Superiority |
| PRID at 4 hour | ANCOVA | < 0.001 | LS means difference | 6.08 | 2-Sided | 95 | 5.02 | 7.14 | Superiority |
| PRID at 4 hour | ANCOVA | < 0.001 | LS means difference | 6.00 | 2-Sided | 95 | 4.94 | 7.05 | Superiority |
| PRID at 5 hour | ANCOVA | 0.438 | LS means difference | 0.31 | 2-Sided | 95 | -0.48 | 1.11 | Superiority |
| PRID at 5 hour | ANCOVA | < 0.001 | LS means difference | 5.47 | 2-Sided | 95 | 4.33 | 6.60 | Superiority |
| PRID at 5 hour | ANCOVA | < 0.001 | LS means difference | 5.15 | 2-Sided | 95 | 4.01 | 6.29 | Superiority |
| PRID at 6 hour | ANCOVA | 0.250 | LS means difference | 0.50 | 2-Sided | 95 | -0.35 | 1.35 | Superiority |
| PRID at 6 hour | ANCOVA | < 0.001 | LS means difference | 4.80 | 2-Sided | 95 | 3.58 | 6.02 | Superiority |
| PRID at 6 hour | ANCOVA | < 0.001 | LS means difference | 4.30 | 2-Sided | 95 | 3.08 | 5.52 | Superiority |
| PRID at 7 hour | ANCOVA | 0.818 | LS means difference | 0.11 | 2-Sided | 95 | -0.80 | 1.01 | Superiority |
| PRID at 7 hour | ANCOVA | < 0.001 | LS means difference | 3.53 | 2-Sided | 95 | 2.23 | 4.82 | Superiority |
| PRID at 7 hour | ANCOVA | < 0.001 | LS means difference | 3.42 | 2-Sided | 95 | 2.12 | 4.71 | Superiority |
| PRID at 8 hour | ANCOVA | 0.698 | LS means difference | 0.18 | 2-Sided | 95 | -0.74 | 1.11 | Superiority |
| PRID at 8 hour | ANCOVA | < 0.001 | LS means difference | 3.02 | 2-Sided | 95 | 1.69 | 4.34 | Superiority |
| PRID at 8 hour | ANCOVA | < 0.001 | LS means difference | 2.83 | 2-Sided | 95 | 1.51 | 4.16 | Superiority |
|
| 1 hour |
|
| 1.5 hour |
|
| 2 hour |
|
| 3 hour |
|
| 4 hour |
|
| 5 hour |
|
| 6 hour |
|
| 7 hour |
|
| 8 hour |
|
| 0.426 |
| LS means difference |
| 0.07 |
| 2-Sided |
| 95 |
| -0.11 |
| 0.25 |
| Superiority |
| PRR score at 0.25 hour | ANCOVA | 0.686 | LS means difference | 0.04 | 2-Sided | 95 | -0.14 | 0.22 | Superiority |
| PRR score at 0.5 hour | ANCOVA | 0.543 | LS means difference | 0.07 | 2-Sided | 95 | -0.15 | 0.29 | Superiority |
| PRR score at 0.5 hour | ANCOVA | < 0.001 | LS means difference | 0.81 | 2-Sided | 95 | 0.49 | 1.12 | Superiority |
| PRR score at 0.5 hour | ANCOVA | < 0.001 | LS means difference | 0.74 | 2-Sided | 95 | 0.42 | 1.05 | Superiority |
| PRR score at 1 hour | ANCOVA | 0.038 | LS means difference | 0.24 | 2-Sided | 95 | 0.01 | 0.46 | Superiority |
| PRR score at 1 hour | ANCOVA | < 0.001 | LS means difference | 2.01 | 2-Sided | 95 | 1.69 | 2.33 | Superiority |
| PRR score at 1 hour | ANCOVA | < 0.001 | LS means difference | 1.78 | 2-Sided | 95 | 1.46 | 2.09 | Superiority |
| PRR score at 1.5 hour | ANCOVA | 0.024 | LS means difference | 0.25 | 2-Sided | 95 | 0.03 | 0.47 | Superiority |
| PRR score at 1.5 hour | ANCOVA | < 0.001 | LS means difference | 2.33 | 2-Sided | 95 | 2.02 | 2.64 | Superiority |
| PRR score at 1.5 hour | ANCOVA | < 0.001 | LS means difference | 2.08 | 2-Sided | 95 | 1.77 | 2.39 | Superiority |
| PRR score at 2 hour | ANCOVA | 0.103 | LS means difference | 0.18 | 2-Sided | 95 | -0.04 | 0.40 | Superiority |
| PRR score at 2 hour | ANCOVA | < 0.001 | LS means difference | 2.40 | 2-Sided | 95 | 2.09 | 2.71 | Superiority |
| PRR score at 2 hour | ANCOVA | < 0.001 | LS means difference | 2.22 | 2-Sided | 95 | 1.91 | 2.53 | Superiority |
| PRR score at 3 hour | ANCOVA | 0.448 | LS means difference | 0.08 | 2-Sided | 95 | -0.13 | 0.29 | Superiority |
| PRR score at 3 hour | ANCOVA | < 0.001 | LS means difference | 2.16 | 2-Sided | 95 | 1.86 | 2.47 | Superiority |
| PRR score at 3 hour | ANCOVA | < 0.001 | LS means difference | 2.08 | 2-Sided | 95 | 1.78 | 2.38 | Superiority |
| PRR score at 4 hour | ANCOVA | 0.997 | LS means difference | 0.00 | 2-Sided | 95 | -0.23 | 0.23 | Superiority |
| PRR score at 4 hour | ANCOVA | < 0.001 | LS means difference | 1.94 | 2-Sided | 95 | 1.61 | 2.28 | Superiority |
| PRR score at 4 hour | ANCOVA | < 0.001 | LS means difference | 1.94 | 2-Sided | 95 | 1.61 | 2.28 | Superiority |
| PRR score at 5 hour | ANCOVA | 0.656 | LS means difference | 0.06 | 2-Sided | 95 | -0.19 | 0.31 | Superiority |
| PRR score at 5 hour | ANCOVA | < 0.001 | LS means difference | 1.73 | 2-Sided | 95 | 1.36 | 2.09 | Superiority |
| PRR score at 5 hour | ANCOVA | < 0.001 | LS means difference | 1.67 | 2-Sided | 95 | 1.31 | 2.03 | Superiority |
| PRR score at 6 hour | ANCOVA | 0.425 | LS means difference | 0.11 | 2-Sided | 94 | -0.16 | 0.38 | Superiority |
| PRR score at 6 hour | ANCOVA | < 0.001 | LS means difference | 1.51 | 2-Sided | 95 | 1.12 | 1.90 | Superiority |
| PRR score at 6 hour | ANCOVA | < 0.001 | LS means difference | 1.40 | 2-Sided | 95 | 1.01 | 1.79 | Superiority |
| PRR score at 7 hour | ANCOVA | 0.841 | LS means difference | -0.03 | 2-Sided | 95 | -0.32 | 0.26 | Superiority |
| PRR score at 7 hour | ANCOVA | < 0.001 | LS means difference | 1.10 | 2-Sided | 95 | 0.69 | 1.52 | Superiority |
| PRR score at 7 hour | ANCOVA | < 0.001 | LS means difference | 1.13 | 2-Sided | 95 | 0.72 | 1.55 | Superiority |
| PRR score at 8 hour | ANCOVA | 0.980 | LS means difference | 0.00 | 95 | -0.30 | 0.30 | Superiority |
| PRR score at 8 hour | ANCOVA | < 0.001 | LS means difference | 0.93 | 2-Sided | 95 | 0.50 | 1.36 | Superiority |
| PRR score at 8 hour | ANCOVA | < 0.001 | LS means difference | 0.93 | 2-Sided | 95 | 0.50 | 1.35 | Superiority |
|
| 1 hour |
|
| 1.5 hour |
|
| 2 hour |
|
| 3 hour |
|
| 4 hour |
|
| 5 hour |
|
| 6 hour |
|
| 7 hour |
|
| 8 hour |
|
| 0.804 |
| LS means difference |
| 0.04 |
| 2-Sided |
| 95 |
| -0.30 |
| 0.39 |
| Superiority |
| PID score at 0.25 hr | ANCOVA | 0.676 | LS means difference | 0.07 | 2-Sided | 95 | -0.27 | 0.42 | Superiority |
| PID score at 0.5 hour | ANCOVA | 0.654 | LS means difference | -0.10 | 2-Sided | 95 | -0.55 | 0.35 | Superiority |
| PID score at 0.5 hour | ANCOVA | < 0.001 | LS means difference | 1.45 | 2-Sided | 95 | 0.81 | 2.10 | Superiority |
| PID score at 0.5 hour | ANCOVA | < 0.001 | LS means difference | 1.55 | 2-Sided | 95 | 0.91 | 2.20 | Superiority |
| PID score at 1 hour | ANCOVA | 0.045 | LS means difference | 0.49 | 2-Sided | 95 | 0.01 | 0.97 | Superiority |
| PID score at 1 hour | ANCOVA | < 0.001 | LS means difference | 4.10 | 95 | 3.41 | 4.78 | Superiority |
| PID score at 1 hour | ANCOVA | < 0.001 | LS means difference | 3.60 | 2-Sided | 95 | 2.92 | 4.29 | Superiority |
| PID score at 1.5 hour | ANCOVA | 0.015 | LS means difference | 0.59 | 2-Sided | 95 | 0.11 | 1.06 | Superiority |
| PID score at 1.5 hour | ANOVA | < 0.001 | LS means difference | 5.03 | 2-Sided | 95 | 4.35 | 5.71 | Superiority |
| PID score at 1.5 hour | ANCOVA | < 0.001 | LS means difference | 4.44 | 2-Sided | 95 | 3.76 | 5.12 | Superiority |
| PID score at 2 hour | ANCOVA | 0.066 | LS means difference | 0.44 | 2-Sided | 95 | -0.03 | 0.91 | Superiority |
| PID score at 2 hour | ANCOVA | < 0.001 | LS means difference | 5.22 | 2-Sided | 95 | 4.54 | 5.89 | Superiority |
| PID score at 2 hour | ANCOVA | < 0.001 | LS means difference | 4.78 | 2-Sided | 95 | 4.10 | 5.45 | Superiority |
| PID score at 3 hour | ANCOVA | 0.186 | LS means difference | 0.32 | 2-Sided | 95 | -0.16 | 0.81 | Superiority |
| PID score at 3 hour | ANCOVA | < 0.001 | LS means difference | 4.66 | 2-Sided | 95 | 3.98 | 5.35 | Superiority |
| PID score at 3 hour | ANCOVA | < 0.001 | LS means difference | 4.34 | 2-Sided | 95 | 3.65 | 5.03 | Superiority |
| PID score at 4 hour | ANCOVA | 0.750 | LS means difference | 0.08 | 2-Sided | 95 | -0.43 | 0.60 | Superiority |
| PID score at 4 hour | ANCOVA | < 0.001 | LS means difference | 4.14 | 2-Sided | 95 | 3.40 | 4.87 | Superiority |
| PID score at 4 hour | ANCOVA | < 0.001 | LS means difference | 4.05 | 2-Sided | 95 | 3.32 | 4.79 | Superiority |
| PID score at 5 hour | ANCOVA | 0.361 | LS means difference | 0.26 | 2-Sided | 95 | -0.30 | 0.81 | Superiority |
| PID score at 5 hour | ANCOVA | < 0.001 | LS means difference | 3.74 | 2-Sided | 95 | 2.95 | 4.53 | Superiority |
| PID score at 5 hour | ANCOVA | < 0.001 | LS means difference | 3.48 | 2-Sided | 95 | 2.69 | 4.27 | Superiority |
| PID score at 6 hour | ANCOVA | 0.195 | LS means difference | 0.39 | 2-Sided | 95 | -0.20 | 0.98 | Superiority |
| PID score at 6 hour | ANCOVA | < 0.001 | LS means difference | 3.29 | 2-Sided | 95 | 2.44 | 4.13 | Superiority |
| PID score at 6 hour | ANCOVA | < 0.001 | LS means difference | 2.90 | 2-Sided | 95 | 2.06 | 3.74 | Superiority |
| PID score at 7 hour | ANCOVA | 0.669 | LS means difference | 0.14 | 2-Sided | 95 | -0.49 | 0.76 | Superiority |
| PID score at 7 hour | ANCOVA | < 0.001 | LS means difference | 2.42 | 2-Sided | 95 | 1.53 | 3.31 | Superiority |
| PID score at 7 hour | ANCOVA | < 0.001 | LS means difference | 2.29 | 2-Sided | 95 | 1.40 | 3.18 | Superiority |
| PID score at 8 hour | ANCOVA | 0.581 | LS means difference | 0.18 | 2-Sided | 95 | -0.46 | 0.82 | Superiority |
| PID score at 8 hour | ANCOVA | < 0.001 | LS means difference | 2.09 | 2-Sided | 95 | 1.18 | 3.00 | Superiority |
| PID score at 8 hour | ANCOVA | < 0.001 | LS means difference | 1.91 | 2-Sided | 95 | 1.00 | 2.82 | Superiority |
P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.
| <0.001 |
| Superiority |
| Gehan-Wilcoxon test | P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms. | <0.001 | Superiority |
P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.
| <0.001 |
| Superiority |
| Gehan-Wilcoxon test | P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms. | <0.001 | Superiority |
P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.
| <0.001 |
| Superiority |
| Gehan-Wilcoxon test | P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms. | <0.001 | Superiority |
| Title | Measurements |
|---|---|
|
| Severe |
|
|