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
The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05089771 1600 mg | Experimental |
| |
| PF-05089771 450 mg | Experimental |
| |
| PF-05089771 150 mg | Experimental |
| |
| Ibuprofen 400 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 | Drug | A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework. | 0 to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peak Pain Relief (PPR) | PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). | 0 to 24 hours |
| Pain Relief (PR) Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Texas Oral Surgery Associates | Austin | Texas | 78705 | United States | ||
| Premier Research Group Limited |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PF-05089771 150 mg | Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale). |
| FG001 | PF-05089771 450 mg | Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| FG002 | PF-05089771 1600 mg | Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| FG003 | Ibuprofen | Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| FG004 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-05089771 150 mg | Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale). |
| 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 | Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework. | Full Analysis Set (FAS): all randomized participants who received at least (>=) 1 dose of study treatment and had >=1 evaluable (more than or equal to [>=] 90 minutes post-dose) PR score. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | 0 to 6 hours |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | PF-05089771 150 mg | Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| C000618268 | PF-05089771 |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively |
|
| PF-05089771 | Drug | A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively |
|
| Placebo | Other | Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively |
|
| PF-05089771 | Drug | A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively |
|
| Placebo | Other | Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively |
|
| Ibuprofen | Drug | 2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively |
|
| Placebo | Other | Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively |
|
| Placebo | Other | Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively |
|
| Placebo | Other | Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively |
|
PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). |
| 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours |
| Pain Intensity Difference (PID) | PID was calculated as pain intensity at baseline (baseline pain severity score range 2 [moderate] to 3 [severe]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 [none] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours |
| Summed Pain Intensity Difference (SPID) | SPID: area under the PID effect curve from 0 to 6 hours (SPID[6]) and 0 to 24 hours (SPID[24]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). | 0 to 6 hours; 0 to 24 hours |
| Total Pain Relief From 0 to 24 Hours (TOTPAR[24]) | TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate | 0 to 24 hours |
| Time to Onset of First Perceptible Pain Relief | Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief. | 0 to 24 hours |
| Time to Onset of Meaningful Pain Relief | Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief. | 0 to 24 hours |
| Time to First Use of Rescue Medication | Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time. | 0 to 24 hours |
| Number of Participants With Global Evaluation of Study Medication | Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication[RM]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) |
| Number of Participants With Study Medication Satisfaction | Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS). | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) |
| Plasma PF-05089771 Concentration | 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose |
| Plasma Ibuprofen Concentration | Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration). | 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to Day 28 (follow-up) |
| Number of Participants With Clinically Significant Laboratory Findings | Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed. | Baseline up to Day 7 to 10 (follow-up) |
| Number of Participants With Clinically Significant Vital Signs | Clinically significant vital signs: supine/sitting pulse rate (PR) less than (<) 40 or more than (>) 120 beats per minute (bpm), standing PR <40 or >140 bpm; systolic blood pressure (BP) >=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP <90 mmHg; diastolic BP >=20 mmHg change from baseline; absolute systolic BP <50 mmHg. | Baseline up to Day 7 to 10 (follow-up) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Clinically significant ECG abnormalities: PR interval >=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was >200 msec; an increase from baseline of >=50% in PR interval when baseline PR was <=200 msec; QRS interval >=140 msec; an increase from baseline of >=50% in QRS interval; corrected QT interval (QTc) >=500 msec. | Baseline up to Day 7 to 10 (follow-up) |
| Austin |
| Texas |
| 78705 |
| United States |
| PPD Development, LP | Austin | Texas | 78744 | United States |
| Other |
|
| BG001 | PF-05089771 450 mg | Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| BG002 | PF-05089771 1600 mg | Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| BG003 | Ibuprofen | Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| BG004 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| PF-05089771 150 mg |
Single oral dose of PF-05089771 150 milligram (mg) -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 millimeter [mm] on a 100 mm Visual Analog Scale [VAS] pain severity rating scale). |
| OG001 | PF-05089771 450 mg | Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| OG002 | PF-05089771 1600 mg | Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| OG003 | Ibuprofen | Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
| OG004 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). |
|
|
| Secondary | Number of Participants With Peak Pain Relief (PPR) | PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | Posted | Number | participants | 0 to 24 hours |
|
|
|
| Secondary | Pain Relief (PR) Score | PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. | Posted | Least Squares Mean | Standard Error | units on a scale | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours |
|
|
|
|
| Secondary | Pain Intensity Difference (PID) | PID was calculated as pain intensity at baseline (baseline pain severity score range 2 [moderate] to 3 [severe]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 [none] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. | Posted | Least Squares Mean | Standard Error | units on a scale | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours |
|
|
|
|
| Secondary | Summed Pain Intensity Difference (SPID) | SPID: area under the PID effect curve from 0 to 6 hours (SPID[6]) and 0 to 24 hours (SPID[24]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 6 hours; 0 to 24 hours |
|
|
|
|
| Secondary | Total Pain Relief From 0 to 24 Hours (TOTPAR[24]) | TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 24 hours |
|
|
|
|
| Secondary | Time to Onset of First Perceptible Pain Relief | Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief. | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | Posted | Median | 90% Confidence Interval | hours | 0 to 24 hours |
|
|
|
|
| Secondary | Time to Onset of Meaningful Pain Relief | Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief. | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | Posted | Median | 90% Confidence Interval | hours | 0 to 24 hours |
|
|
|
|
| Secondary | Time to First Use of Rescue Medication | Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time. | FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | Posted | Median | 90% Confidence Interval | hours | 0 to 24 hours |
|
|
|
|
| Secondary | Number of Participants With Global Evaluation of Study Medication | Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication[RM]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. | FAS: all randomized participants who received >=1 dose of study treatment, had >=1 evaluable (>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure. | Posted | Number | participants | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) |
|
|
|
| Secondary | Number of Participants With Study Medication Satisfaction | Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS). | FAS: all randomized participants who received >=1 dose of study treatment, had >=1 evaluable (>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure. | Posted | Number | participants | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) |
|
|
|
| Secondary | Plasma PF-05089771 Concentration | Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose |
|
|
|
| Secondary | Plasma Ibuprofen Concentration | Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration). | Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Day 28 (follow-up) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Laboratory Findings | Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed. | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Day 7 to 10 (follow-up) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Vital Signs | Clinically significant vital signs: supine/sitting pulse rate (PR) less than (<) 40 or more than (>) 120 beats per minute (bpm), standing PR <40 or >140 bpm; systolic blood pressure (BP) >=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP <90 mmHg; diastolic BP >=20 mmHg change from baseline; absolute systolic BP <50 mmHg. | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Day 7 to 10 (follow-up) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Clinically significant ECG abnormalities: PR interval >=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was >200 msec; an increase from baseline of >=50% in PR interval when baseline PR was <=200 msec; QRS interval >=140 msec; an increase from baseline of >=50% in QRS interval; corrected QT interval (QTc) >=500 msec. | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Day 7 to 10 (follow-up) |
|
|
|
| 0 |
| 55 |
| 16 |
| 55 |
| EG001 | PF-05089771 450 mg | Single oral dose of PF-05089771 450 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). | 0 | 54 | 20 | 54 |
| EG002 | PF-05089771 1600 mg | Single oral dose of PF-05089771 1600 mg -dispersion along with 2 placebo tablets matched to ibuprofen 200 mg tablet orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). | 0 | 54 | 23 | 54 |
| EG003 | Ibuprofen | Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). | 0 | 36 | 10 | 36 |
| EG004 | Placebo | Single oral dose of 2 placebo tablets matched to ibuprofen tablets along with placebo matched to PF-05089771-dispersion orally following unilateral surgical extraction of two-third molars, one of which was a partial or full bony mandibular impaction. Study treatment was administered within 5 hours post-surgery when the pain intensity reached the required moderate to severe level (score of 2 or greater on a 4-point categorical pain severity rating scale and a score of at least 50 mm on a 100 mm VAS pain severity rating scale). | 0 | 36 | 12 | 36 |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Alveolar osteitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | 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.
| A Little |
|
| Some |
|
| A Lot |
|
| Complete |
|
| 30 Minutes |
|
| 45 Minutes |
|
| 60 Minutes |
|
| 90 Minutes |
|
| 2 Hours |
|
| 3 Hours |
|
| 4 Hours |
|
| 6 Hours |
|
| 8 Hours |
|
| 24 Hours |
|
|
15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. |
| LS Mean Difference |
| 0.09 |
| Standard Error of the Mean |
| 0.18 |
| 2-Sided |
| 90 |
| -0.20 |
| 0.39 |
| Superiority or Other |
| 15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.02 | Standard Error of the Mean | 0.18 | 2-Sided | 90 | -0.28 | 0.32 | Superiority or Other |
| 15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | -0.09 | Standard Error of the Mean | 0.20 | 2-Sided | 90 | -0.41 | 0.24 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.06 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | -0.32 | 0.44 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.39 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | 0.01 | 0.77 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.16 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | -0.22 | 0.54 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.66 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | 0.24 | 1.07 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.02 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | -0.37 | 0.42 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.39 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | -0.00 | 0.78 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.11 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | -0.29 | 0.50 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.02 | Standard Error of the Mean | 0.26 | 2-Sided | 90 | 0.59 | 1.45 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.20 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | -0.21 | 0.62 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.34 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | -0.07 | 0.76 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.30 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | -0.11 | 0.72 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.30 | Standard Error of the Mean | 0.27 | 2-Sided | 90 | 0.85 | 1.75 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.39 | Standard Error of the Mean | 0.26 | 2-Sided | 90 | -0.04 | 0.81 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.32 | Standard Error of the Mean | 0.26 | 2-Sided | 90 | -0.10 | 0.75 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.38 | Standard Error of the Mean | 0.26 | 2-Sided | 90 | -0.05 | 0.81 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.69 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | 1.22 | 2.15 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.50 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | 0.01 | 0.99 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.54 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | 0.05 | 1.03 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.45 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | -0.04 | 0.94 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.79 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | 1.26 | 2.31 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.59 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | 0.06 | 1.11 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.64 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | 0.11 | 1.17 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.63 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | 0.11 | 1.15 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.87 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | 1.33 | 2.40 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.49 | Standard Error of the Mean | 0.34 | 2-Sided | 90 | -0.07 | 1.05 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.33 | Standard Error of the Mean | 0.35 | 2-Sided | 90 | -0.24 | 0.91 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.43 | Standard Error of the Mean | 0.34 | 2-Sided | 90 | -0.13 | 0.98 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.61 | Standard Error of the Mean | 0.34 | 2-Sided | 90 | 1.05 | 2.17 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | -0.05 | Standard Error of the Mean | 0.42 | 2-Sided | 90 | -0.74 | 0.64 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | -0.15 | Standard Error of the Mean | 0.43 | 2-Sided | 90 | -0.86 | 0.56 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.11 | Standard Error of the Mean | 0.42 | 2-Sided | 90 | -0.57 | 0.80 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.90 | Standard Error of the Mean | 0.41 | 2-Sided | 90 | 0.22 | 1.58 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | -0.17 | Standard Error of the Mean | 0.46 | 2-Sided | 90 | -0.93 | 0.59 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | -0.18 | Standard Error of the Mean | 0.48 | 2-Sided | 90 | -0.98 | 0.62 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | -0.30 | Standard Error of the Mean | 0.45 | 2-Sided | 90 | -1.05 | 0.45 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.27 | Standard Error of the Mean | 0.45 | 2-Sided | 90 | -0.47 | 1.02 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.63 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 0.15 | 1.11 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.24 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | -0.27 | 0.74 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.44 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | -0.03 | 0.91 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.19 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | -0.30 | 0.67 | Superiority or Other |
| 30 Minutes |
|
| 45 Minutes |
|
| 60 Minutes |
|
| 90 Minutes |
|
| 2 Hours |
|
| 3 Hours |
|
| 4 Hours |
|
| 6 Hours |
|
| 8 Hours |
|
| 24 Hours |
|
15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. |
| LS Mean Difference |
| 0.20 |
| Standard Error of the Mean |
| 0.10 |
| 2-Sided |
| 90 |
| 0.03 |
| 0.37 |
| Superiority or Other |
| 15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.07 | Standard Error of the Mean | 0.10 | 2-Sided | 90 | -0.10 | 0.24 | Superiority or Other |
| 15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.02 | Standard Error of the Mean | 0.11 | 2-Sided | 90 | -0.16 | 0.21 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.20 | Standard Error of the Mean | 0.15 | 2-Sided | 90 | -0.06 | 0.45 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.44 | Standard Error of the Mean | 0.15 | 2-Sided | 90 | 0.19 | 0.70 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.29 | Standard Error of the Mean | 0.15 | 2-Sided | 90 | 0.04 | 0.54 | Superiority or Other |
| 30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.59 | Standard Error of the Mean | 0.17 | 2-Sided | 90 | 0.32 | 0.87 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.12 | Standard Error of the Mean | 0.17 | 2-Sided | 90 | -0.16 | 0.40 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.40 | Standard Error of the Mean | 0.17 | 2-Sided | 90 | 0.12 | 0.68 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.23 | Standard Error of the Mean | 0.17 | 2-Sided | 90 | -0.05 | 0.50 | Superiority or Other |
| 45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.71 | Standard Error of the Mean | 0.18 | 2-Sided | 90 | 0.40 | 1.01 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.10 | Standard Error of the Mean | 0.18 | 2-Sided | 90 | -0.19 | 0.40 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.19 | Standard Error of the Mean | 0.18 | 2-Sided | 90 | -0.10 | 0.49 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.13 | Standard Error of the Mean | 0.18 | 2-Sided | 90 | -0.16 | 0.43 | Superiority or Other |
| 60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.74 | Standard Error of the Mean | 0.20 | 2-Sided | 90 | 0.41 | 1.06 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.33 | Standard Error of the Mean | 0.19 | 2-Sided | 90 | 0.01 | 0.64 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.31 | Standard Error of the Mean | 0.19 | 2-Sided | 90 | -0.01 | 0.62 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.39 | Standard Error of the Mean | 0.19 | 2-Sided | 90 | 0.08 | 0.71 | Superiority or Other |
| 90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.26 | Standard Error of the Mean | 0.21 | 2-Sided | 90 | 0.92 | 1.61 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.40 | Standard Error of the Mean | 0.22 | 2-Sided | 90 | 0.04 | 0.76 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.33 | Standard Error of the Mean | 0.22 | 2-Sided | 90 | -0.03 | 0.69 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.41 | Standard Error of the Mean | 0.22 | 2-Sided | 90 | 0.05 | 0.77 | Superiority or Other |
| 2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.30 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | 0.92 | 1.68 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.55 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | 0.16 | 0.95 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.57 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | 0.17 | 0.97 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.63 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | 0.24 | 1.03 | Superiority or Other |
| 3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.38 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | 0.97 | 1.78 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.50 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | 0.08 | 0.92 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.41 | Standard Error of the Mean | 0.26 | 2-Sided | 90 | -0.03 | 0.84 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.51 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | 0.09 | 0.93 | Superiority or Other |
| 4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 1.17 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | 0.75 | 1.59 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.23 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | -0.27 | 0.72 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.14 | Standard Error of the Mean | 0.31 | 2-Sided | 90 | -0.37 | 0.65 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.27 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | -0.23 | 0.77 | Superiority or Other |
| 6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.82 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | 0.33 | 1.31 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.32 | Standard Error of the Mean | 0.34 | 2-Sided | 90 | -0.24 | 0.89 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.34 | Standard Error of the Mean | 0.36 | 2-Sided | 90 | -0.25 | 0.94 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.25 | Standard Error of the Mean | 0.34 | 2-Sided | 90 | -0.31 | 0.80 | Superiority or Other |
| 8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.64 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | 0.08 | 1.19 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.45 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | 0.07 | 0.83 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.04 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | -0.36 | 0.44 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.31 | Standard Error of the Mean | 0.22 | 2-Sided | 90 | -0.07 | 0.68 | Superiority or Other |
| 24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. | LS Mean Difference | 0.06 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | -0.32 | 0.45 | Superiority or Other |
| SIPD(24) |
|
SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. |
| LS Mean Difference |
| 1.69 |
| Standard Error of the Mean |
| 0.99 |
| 2-Sided |
| 90 |
| 0.05 |
| 3.33 |
| Superiority or Other |
| SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. | LS Mean Difference | 2.34 | Standard Error of the Mean | 1.00 | 2-Sided | 90 | 0.69 | 3.99 | Superiority or Other |
| SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. | LS Mean Difference | 6.99 | Standard Error of the Mean | 1.09 | 2-Sided | 90 | 5.19 | 8.79 | Superiority or Other |
| SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. | LS Mean Difference | 9.80 | Standard Error of the Mean | 4.74 | 2-Sided | 90 | 1.97 | 17.63 | Superiority or Other |
| SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. | LS Mean Difference | 3.55 | Standard Error of the Mean | 4.74 | 2-Sided | 90 | -4.28 | 11.37 | Superiority or Other |
| SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. | LS Mean Difference | 10.82 | Standard Error of the Mean | 4.76 | 2-Sided | 90 | 2.97 | 18.68 | Superiority or Other |
| SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate. | LS Mean Difference | 22.39 | Standard Error of the Mean | 5.19 | 2-Sided | 90 | 13.82 | 30.97 | Superiority or Other |
LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.
| LS Mean Difference |
| 4.18 |
| Standard Error of the Mean |
| 6.66 |
| 2-Sided |
| 90 |
| -6.82 |
| 15.18 |
| Superiority or Other |
| LS Mean Difference | 12.57 | Standard Error of the Mean | 6.69 | 2-Sided | 90 | 1.52 | 23.61 | Superiority or Other |
| LS Mean Difference | 32.56 | Standard Error of the Mean | 7.30 | 2-Sided | 90 | 20.51 | 44.61 | Superiority or Other |
HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.
| Hazard Ratio (HR) |
| 1.3 |
| 2-Sided |
| 90 |
| 0.9 |
| 1.9 |
| Superiority or Other |
| HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects. | Hazard Ratio (HR) | 1.1 | 2-Sided | 90 | 0.7 | 1.6 | Superiority or Other |
| HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects. | Hazard Ratio (HR) | 1.6 | 2-Sided | 90 | 1.0 | 2.4 | Superiority or Other |
| Hazard Ratio (HR) |
| 2.6 |
| 2-Sided |
| 90 |
| 1.4 |
| 4.9 |
| Superiority or Other |
| HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects. | Hazard Ratio (HR) | 2.2 | 2-Sided | 90 | 1.1 | 4.1 | Superiority or Other |
| HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects. | Hazard Ratio (HR) | 5.3 | 2-Sided | 90 | 2.8 | 9.9 | Superiority or Other |
| Hazard Ratio (HR) |
| 0.8 |
| 2-Sided |
| 90 |
| 0.5 |
| 1.2 |
| Superiority or Other |
| HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects. | Hazard Ratio (HR) | 0.5 | 2-Sided | 90 | 0.3 | 0.8 | Superiority or Other |
| HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects. | Hazard Ratio (HR) | 0.4 | 2-Sided | 90 | 0.2 | 0.6 | Superiority or Other |
|
| Hour 6: Fair |
|
|
| Hour 6: Good |
|
|
| Hour 6: Very Good |
|
|
| Hour 6: Excellent |
|
|
| Hour 24: Poor |
|
|
| Hour 24: Fair |
|
|
| Hour 24: Good |
|
|
| Hour 24: Very Good |
|
|
| Hour 24: Excellent |
|
|
| Prior to RM: Poor |
|
|
| Prior to RM: Fair |
|
|
| Prior to RM: Good |
|
|
| Prior to RM: Very Good |
|
|
| Prior to RM: Excellent |
|
|
|
| SM OP, Hour 6: SS |
|
|
| SM OP, Hour 6: NSND |
|
|
| SM OP, Hour 6: SD |
|
|
| SM OP, Hour 6: VD |
|
|
| SM OP, Hour 24: VS |
|
|
| SM OP, Hour 24: SS |
|
|
| SM OP, Hour 24: NSND |
|
|
| SM OP, Hour 24: SD |
|
|
| SM OP, Hour 24: VD |
|
|
| SM OP, Prior to RM: VS |
|
|
| SM OP, Prior to RM: SS |
|
|
| SM OP, Prior to RM: NSND |
|
|
| SM OP, Prior to RM: SD |
|
|
| SM OP, Prior to RM: VD |
|
|
| SM PR, Hour 6: VS |
|
|
| SM PR, Hour 6: SS |
|
|
| SM PR, Hour 6: NSND |
|
|
| SM PR, Hour 6: SD |
|
|
| SM PR, Hour 6: VD |
|
|
| SM PR, Hour 24: VS |
|
|
| SM PR, Hour 24: SS |
|
|
| SM PR, Hour 24: NSND |
|
|
| SM PR, Hour 24: SD |
|
|
| SM PR, Hour 24: VD |
|
|
| SM PR, Prior to RM: VS |
|
|
| SM PR, Prior to RM: SS |
|
|
| SM PR, Prior to RM: NSND |
|
|
| SM PR, Prior to RM: SD |
|
|
| SM PR, Prior to RM: VD |
|
|
| 0.5 hour |
|
| 1 hour |
|
| 2 hours |
|
| 4 hours |
|
| 6 hours |
|
| 8 hours |
|
| 10 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| (R)-Ibuprofen 2 hours |
|
| (R)-Ibuprofen 4 hours |
|
| (R)-Ibuprofen 6 hours |
|
| (R)-Ibuprofen 8 hours |
|
| (R)-Ibuprofen 10 hours |
|
| (R)-Ibuprofen 24 hours |
|
| (S)-Ibuprofen 0 hour |
|
| (S)-Ibuprofen 0.5 hour |
|
| (S)-Ibuprofen 1 hour |
|
| (S)-Ibuprofen 2 hours |
|
| (S)-Ibuprofen 4 hours |
|
| (S)-Ibuprofen 6 hours |
|
| (S)-Ibuprofen 8 hours |
|
| (S)-Ibuprofen 10 hours |
|
| (S)-Ibuprofen 24 hours |
|
| Serious Adverse Events |
|