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

Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464983
• Other study ID #: 11220
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2011
• Last updated: December 23, 2014
• Start date: January 2004
• Est. completion date: August 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1115
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache
• Tension-Type Headache (Episodic)

Intervention

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
• Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
• Ibuprofen
Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
• Ibuprofen
Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
• Placebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication		2 hours post dose	No
Secondary	Headache pain relief measured serially on a categorical scale		Until 4 hours post dose	No
Secondary	Measuring the functional ability on conducting everydays activity on a 4 point categorical scale		2 and 24 hours post dose	No
Secondary	Global assessment of pain therapy		24 hours post dose	No
Secondary	Safety - assessment of adverse events		Up to 10 weeks after screening	Yes

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