Study Comparing the Efficacy of Two Ibuprofen Formulations

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 placebo gels capsules delivered as a single dose.

2

Group Type ACTIVE_COMPARATOR

ibuprofen Formulation 1

Intervention Type DRUG

2 marketed ibuprofen gels

3

Group Type ACTIVE_COMPARATOR

ibuprofen Formulation 2

Intervention Type DRUG

2 marketed ibuprofen gels

Interventions

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placebo

2 placebo gels capsules delivered as a single dose.

Intervention Type DRUG

ibuprofen Formulation 1

2 marketed ibuprofen gels

Intervention Type DRUG

ibuprofen Formulation 2

2 marketed ibuprofen gels

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes