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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Novel Ibuprofen; Drug: Standard Ibuprofen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01077973

AH-09-11

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

Treatment A

Experimental group

Treatment:

Drug: Novel Ibuprofen

Treatment B

Active Comparator group

Treatment:

Drug: Standard Ibuprofen

Treatment C

Placebo Comparator group

Treatment:

Drug: Placebo