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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01464983
First received: May 17, 2011
Last updated: November 7, 2011
Last verified: November 2011
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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 June 17, 2013