Clinical trial NCT01464983: Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
Official title: A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Tension-Type Headache
Tension-Type Headache (Episodic)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 1115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Headache pain relief measured serially on a categorical scale
timeFrame: Until 4 hours post dose
measure: Measuring the functional ability on conducting everydays activity on a 4 point categorical scale
timeFrame: 2 and 24 hours post dose
measure: Global assessment of pain therapy
timeFrame: 24 hours post dose
measure: Safety - assessment of adverse events
timeFrame: Up to 10 weeks after screening
Other outcomes:
Locations:
city: Reading
country: United Kingdom
state: Berkshire
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Chorley
country: United Kingdom
state: Lancashire
city: Wigan
country: United Kingdom
state: Lancashire
city: Liverpool
country: United Kingdom
state: Merseyside
city: Liverpool
country: United Kingdom
state: Merseyside
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Glasgow
country: United Kingdom
state: Strathclyde
city: Birmingham
country: United Kingdom
state: West Midlands
city: Coventry
country: United Kingdom
state: West Midlands
city: Wolverhampton
country: United Kingdom
state: West Midlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: