Study Comparing the Efficacy of Two Ibuprofen Formulations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00740857|
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : August 12, 2010
Last Update Posted : June 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: placebo Drug: ibuprofen Formulation 1 Drug: ibuprofen Formulation 2||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Study Comparing the Efficacy of Two Ibuprofen Formulations|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
|Placebo Comparator: 1||
2 placebo gels capsules delivered as a single dose.
|Active Comparator: 2||
Drug: ibuprofen Formulation 1
2 marketed ibuprofen gels
|Active Comparator: 3||
Drug: ibuprofen Formulation 2
2 marketed ibuprofen gels
- Time to Meaningful Pain Relief [ Time Frame: 0-6 hours ]Subjects evaluated the time to "First Perceptible" Relief by depressing a stopwatch at the moment they first began to experience "perceptible" relief and the time to "Meaningful" Relief by depressing a second stopwatch at the moment they first began to experience "meaningful" relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.
- Pain Intensity Difference (PID) Scores at Each Individual Time Points [ Time Frame: 0-6 hours ]PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.
- Pain Relief (PR) Scores at Individual Time Points [ Time Frame: 0-6 hours ]Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.
- Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).
- Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points [ Time Frame: 0-6 hours ]PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).
- Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).
- Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ]TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)
- Time to First Perceptible Relief [ Time Frame: 0-6 hours ]The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740857
|United States, Utah|
|Salt Lake City, Utah, United States, 84124|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|