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

Phase 4

Completed

• Conditions: Tension-Type Headache; Tension-Type Headache (Episodic); Headache
• Interventions: Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Placebo; Drug: Ibuprofen

• Registration Number: NCT01464983
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study Completion: 2004-08
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Acetylsalicylic acid (Aspirin, BAYE4465)	-
Arm 2	Acetylsalicylic acid (Aspirin, BAYE4465)	-
Arm 5	Placebo	-
Arm 4	Ibuprofen	-
Arm 3	Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication	2 hours post dose

Secondary Outcome Measures

Name	Time	Method
Measuring the functional ability on conducting everydays activity on a 4 point categorical scale	2 and 24 hours post dose
Global assessment of pain therapy	24 hours post dose
Safety - assessment of adverse events	Up to 10 weeks after screening
Headache pain relief measured serially on a categorical scale	Until 4 hours post dose