Study Comparing the Efficacy of Two Ibuprofen Formulations

Phase 4CompletedNCT00740857

Wyeth is now a wholly owned subsidiary of Pfizer211 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

211

Conditions

Pain

Interventions

placeboDRUG

2 placebo gels capsules delivered as a single dose.

ibuprofen Formulation 1DRUG

2 marketed ibuprofen gels

ibuprofen Formulation 2DRUG

2 marketed ibuprofen gels

Eligibility

Sex: ALLMin age: 16 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: 0-6 hours

Secondary Outcomes

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.

Time frame: 0-6 hours

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.

Time frame: 0-6 hours

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).

Time frame: 0-2 and 0-6 hours

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).

Data from ClinicalTrials.gov

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