check_circleStudy Completed

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

Bayer Identifier:

11220

ClinicalTrials.gov Identifier:

NCT01464983

EudraCT Number:

Not Available

EU CT Number:

Not Available
Placebo and active controlled, double dummy study to compare efficacy of Aspirin and Ibuprofen in treatment of episodic tension-type headache

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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.
  • - 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
January 2004 - August 2004
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Birmingham, B15 2SQ, United Kingdom
Completed
Coventry, CV1 2TZ, United Kingdom
Completed
Chorley, PR7 1NY, United Kingdom
Completed
Liverpool, L22 0LG, United Kingdom
Completed
Liverpool, L1 9AD, United Kingdom
Completed
Reading, RG2 7AG, United Kingdom
Completed
Wolverhampton, WV10 9RU, United Kingdom
Completed
Wigan, WN6 9EW, United Kingdom
Completed
Cardiff, CF14 5GJ, United Kingdom
Completed
Glasgow, G20 OSP, United Kingdom
Completed
Glasgow, G20 OSP, United Kingdom
Completed
Manchester, M15 6SX, United Kingdom

Primary Outcome

  • Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
    date_rangeTime Frame:
    2 hours post dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Headache pain relief measured serially on a categorical scale
    date_rangeTime Frame:
    Until 4 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • Measuring the functional ability on conducting everydays activity on a 4 point categorical scale
    date_rangeTime Frame:
    2 and 24 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • Global assessment of pain therapy
    date_rangeTime Frame:
    24 hours post dose
    enhanced_encryption
    Safety Issue:
    no
  • Safety - assessment of adverse events
    date_rangeTime Frame:
    Up to 10 weeks after screening
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
5

Additional Information

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