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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01464983
First received: May 17, 2011
Last updated: November 7, 2011
Last verified: November 2011
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache pain relief measured serially on a categorical scale [ Time Frame: Until 4 hours post dose ] [ Designated as safety issue: No ]
  • Measuring the functional ability on conducting everydays activity on a 4 point categorical scale [ Time Frame: 2 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Global assessment of pain therapy [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
  • Safety - assessment of adverse events [ Time Frame: Up to 10 weeks after screening ] [ Designated as safety issue: Yes ]

Enrollment: 1065
Study Start Date: January 2004
Study Completion Date: August 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464983

Locations
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, L22 0LG
Liverpool, Merseyside, United Kingdom, L1 9AD
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care, Inc.
ClinicalTrials.gov Identifier: NCT01464983     History of Changes
Other Study ID Numbers: 11220
Study First Received: May 17, 2011
Last Updated: November 7, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Aspirin
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014