Trial Condition(s):

Headache, Tension-Type Headache, Tension-Type Headache (episodic)

Placebo and active controlled, double dummy study to compare efficacy of Aspirin and Ibuprofen in treatment of episodic tension-type headache

Bayer Identifier:

11220

ClinicalTrials.gov Identifier:

NCT01464983

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
1115
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Birmingham, United Kingdom, B15 2SQ

Status
Completed
 
Locations

Investigative Site

Coventry, United Kingdom, CV1 2TZ

Status
Completed
 
Locations

Investigative Site

Chorley, United Kingdom, PR7 1NY

Status
Completed
 
Locations

Investigative Site

Liverpool, United Kingdom, L22 0LG

Status
Completed
 
Locations

Investigative Site

Liverpool, United Kingdom, L1 9AD

Status
Completed
 
Locations

Investigative Site

Reading, United Kingdom, RG2 7AG

Status
Completed
 
Locations

Investigative Site

Wolverhampton, United Kingdom, WV10 9RU

Status
Completed
 
Locations

Investigative Site

Wigan, United Kingdom, WN6 9EW

Status
Completed
 
Locations

Investigative Site

Cardiff, United Kingdom, CF14 5GJ

Status
Completed
 
Locations

Investigative Site

Glasgow, United Kingdom, G20 OSP

Status
Completed
 
Locations

Investigative Site

Manchester, United Kingdom, M15 6SX

Status
Completed
 

Trial Design