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Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01464983
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : December 25, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Headache Tension-Type Headache Tension-Type Headache (Episodic) Drug: Acetylsalicylic acid (Aspirin, BAYE4465) Drug: Ibuprofen Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: Arm 1 Drug: 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

Experimental: Arm 2 Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen

Active Comparator: Arm 3 Drug: Ibuprofen
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid

Active Comparator: Arm 4 Drug: Ibuprofen
Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid

Placebo Comparator: Arm 5 Drug: Placebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose

Primary Outcome Measures :
  1. Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication [ Time Frame: 2 hours post dose ]

Secondary Outcome Measures :
  1. Headache pain relief measured serially on a categorical scale [ Time Frame: Until 4 hours post dose ]
  2. Measuring the functional ability on conducting everydays activity on a 4 point categorical scale [ Time Frame: 2 and 24 hours post dose ]
  3. Global assessment of pain therapy [ Time Frame: 24 hours post dose ]
  4. Safety - assessment of adverse events [ Time Frame: Up to 10 weeks after screening ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01464983

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United Kingdom
Reading, Berkshire, United Kingdom, RG2 7AG
Manchester, Greater Manchester, United Kingdom, M15 6SX
Chorley, Lancashire, United Kingdom, PR7 1NY
Wigan, Lancashire, United Kingdom, WN6 9EW
Liverpool, Merseyside, United Kingdom, L1 9AD
Liverpool, Merseyside, United Kingdom, L22 0LG
Cardiff, South Glamorgan, United Kingdom, CF14 5GJ
Glasgow, Strathclyde, United Kingdom, G81 2DR
Birmingham, West Midlands, United Kingdom, B15 2SQ
Coventry, West Midlands, United Kingdom, CV1 2TZ
Wolverhampton, West Midlands, United Kingdom, WV10 9RU
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT01464983    
Other Study ID Numbers: 11220
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Tension-Type Headache
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors