Study Comparing the Efficacy of Two Ibuprofen Formulations

Pain Clinical Trial

Official title:

A Study Comparing the Efficacy of Two Ibuprofen Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740857
• Other study ID #: PV-08-24
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2008
• Last updated: June 1, 2011
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: June 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

Inclusion criteria :

• Outpatients with post-operative pain following surgical extraction of third molars,

• examined by the attending dentist or physician and medically cleared to participate in the study,

• in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

• any serious medical condition,

• acute localized dental infection at the time of surgery ,

• females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• placebo
2 placebo gels capsules delivered as a single dose.
• ibuprofen Formulation 1
2 marketed ibuprofen gels
• ibuprofen Formulation 2
2 marketed ibuprofen gels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Meaningful Pain Relief	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.	0-6 hours	No
Secondary	Pain Intensity Difference (PID) Scores at Each Individual Time Points	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.	0-6 hours	No
Secondary	Pain Relief (PR) Scores at Individual Time Points	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.	0-6 hours	No
Secondary	Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours 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).	0-2 and 0-6 hours	No
Secondary	Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points	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).	0-6 hours	No
Secondary	Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours 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).	0-2 and 0-6 hours	No
Secondary	Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours 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)	0-2 and 0-6 hours	No
Secondary	Time to First Perceptible Relief	The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.	0-6 hours	No