Study Comparing the Efficacy of Two Ibuprofen Formulations

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: ibuprofen Formulation 1; Drug: ibuprofen Formulation 2; Drug: placebo

• Registration Number: NCT00740857
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-10-30
• Results First Submitted QC: 2010-07-15
• Results First Posted: 2010-08-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ibuprofen Formulation 1	-
3	ibuprofen Formulation 2	-
1	placebo	-

Primary Outcome Measures

Name	Time	Method
Time to Meaningful Pain Relief	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.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID) Scores at Each Individual Time Points	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	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	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	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	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	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	0-6 hours	The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.