Trial · NCT01512160
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | 0 to 6 hours | TOTPAR \[6\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \[6\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR. |
| 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 | Time-specific Pain Relief (PR) Score | 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM) | PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points. |
| Secondary | Time-specific Pain Intensity Difference (PID) Score | 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM | Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. |
| Secondary | Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours | 0 to 6, 0 to 24 hours | Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief. |
| Secondary | Total Pain Relief (TOTPAR) Score From 0 to 24 Hours | 0 to 24 hours | TOTPAR \[24\] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR \[24\]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR. |
| Secondary | Time to Onset of First Perceptible Pain Relief (PR) | 0 to 24 hours | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. |
| Secondary | Time to Onset of First Meaningful Pain Relief (PR) | 0 to 24 hours | Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. |
| Secondary | Time to First Use of Rescue Medication | 1.5 to 24 hours | Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time. |
| Secondary | Number of Participants With Rescue Medication | 0 to 24 hours | Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication. |
| Secondary | Participant Global Evaluation of Study Medication | 6, 24 hours, prior to RM | Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor. |
| Secondary | Participant Satisfaction Questionnaire | 6, 24 hours, prior to RM | Participant's response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04531083 | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083 | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | |
| Secondary | Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083 | 0 (pre-dose), 1, 2, 4, 6 hours post-dose | AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration. |
| Secondary | Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083 | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ibuprofen | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | |
| Secondary | Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen | 0 (pre-dose), 1, 2, 4, 6 hours post-dose | AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration. |
| Secondary | Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen | 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration. |
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.
For software
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