Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Group Type EXPERIMENTAL

Novel Ibuprofen

Intervention Type DRUG

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo

Treatment B

Group Type ACTIVE_COMPARATOR

Standard Ibuprofen

Intervention Type DRUG

Single-dose of standard ibuprofen (400mg) plus placebo

Treatment C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single-dose of placebo

Interventions

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Novel Ibuprofen

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo

Intervention Type DRUG

Standard Ibuprofen

Single-dose of standard ibuprofen (400mg) plus placebo

Intervention Type DRUG

Placebo

Single-dose of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females at least 18 years to 65 years of age
* A diagnosis of an episodic tension-type headache, as defined by the International Headache Society
* A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics

Exclusion Criteria

* Pregnancy or breast-feeding
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
* History of stomach ulcers, stomach bleed, or other bleeding disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No