Trial · NCT01529346
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | 0 to 6 hours | 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. |
| Secondary | Number of Participants With Peak Pain Relief (PPR) | 0 to 24 hours | 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). |
| Secondary | Pain Relief (PR) Score | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours | PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). |
| Secondary | Pain Intensity Difference (PID) | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours | 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). |
| Secondary | Summed Pain Intensity Difference (SPID) | 0 to 6 hours; 0 to 24 hours | 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). |
| Secondary | Total Pain Relief From 0 to 24 Hours (TOTPAR[24]) | 0 to 24 hours | 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 |
| Secondary | Time to Onset of First Perceptible Pain Relief | 0 to 24 hours | 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. |
| Secondary | Time to Onset of Meaningful Pain Relief | 0 to 24 hours | 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. |
| Secondary | Time to First Use of Rescue Medication | 0 to 24 hours | 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. |
| Secondary | Number of Participants With Global Evaluation of Study Medication | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) | 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. |
| Secondary | Number of Participants With Study Medication Satisfaction | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) | 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). |
| Secondary | Plasma PF-05089771 Concentration | 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose | |
| Secondary | Plasma Ibuprofen Concentration | 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose | 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). |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Day 28 (follow-up) | 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. |
| Secondary | Number of Participants With Clinically Significant Laboratory Findings | Baseline up to Day 7 to 10 (follow-up) | 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. |
| Secondary | Number of Participants With Clinically Significant Vital Signs | Baseline up to Day 7 to 10 (follow-up) | 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. |
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to Day 7 to 10 (follow-up) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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