Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
NCT ID: NCT01464983
Last Updated: 2014-12-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1115 participants
INTERVENTIONAL
2004-01-31
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
Arm 2
Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
Arm 3
Ibuprofen
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
Arm 4
Ibuprofen
Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
Arm 5
Placebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
Interventions
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Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
Ibuprofen
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
Ibuprofen
Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
Placebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Reading, Berkshire, United Kingdom
Manchester, Greater Manchester, United Kingdom
Chorley, Lancashire, United Kingdom
Wigan, Lancashire, United Kingdom
Liverpool, Merseyside, United Kingdom
Liverpool, Merseyside, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Glasgow, Strathclyde, United Kingdom
Birmingham, West Midlands, United Kingdom
Coventry, West Midlands, United Kingdom
Wolverhampton, West Midlands, United Kingdom
Countries
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Other Identifiers
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11220
Identifier Type: -
Identifier Source: org_study_id