Status:
COMPLETED
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
Lead Sponsor:
Bayer
Conditions:
Headache
Tension-Type Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
1115 Patients enrolled
Trial Details
Trial ID
NCT01464983
Start Date
January 1 2004
End Date
August 1 2004
Last Update
December 25 2014
Active Locations (11)
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1
Reading, Berkshire, United Kingdom, RG2 7AG
2
Manchester, Greater Manchester, United Kingdom, M15 6SX
3
Chorley, Lancashire, United Kingdom, PR7 1NY
4
Wigan, Lancashire, United Kingdom, WN6 9EW