Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg Aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. The study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Aspirin; Ibuprofen

Criteria

Inclusion Criteria:

• Ambulatory male or female, 18 to 65 years of age

• Normal blood pressure

• Patients suffering from episodic tension-type headache

• Headache lasting from 30 minutes to 7 days

• Headache had at least two of the following characteristics:

Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.

• Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.

Exclusion Criteria:

• Other headaches, including migraine, that required medical treatment

• Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)

• Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease

• Mental illness, including depression

• Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams

• Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception

• Participating in any other clinical study or had done within the previous 4 weeks

• Had been previously enrolled in this study