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

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

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.

Study Overview

• Status: Completed
• Conditions: Headache; Tension-Type Headache; Tension-Type Headache (Episodic)
• Intervention / Treatment: Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Ibuprofen; Drug: Ibuprofen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1115
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 7AG
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M15 6SX
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 1NY
    • Wigan, Lancashire, United Kingdom, WN6 9EW
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L22 0LG
    • Liverpool, Merseyside, United Kingdom, L1 9AD
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 5GJ
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G81 2DR
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2SQ
    • Coventry, West Midlands, United Kingdom, CV1 2TZ
    • Wolverhampton, West Midlands, United Kingdom, WV10 9RU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / 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; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
EXPERIMENTAL: Arm 2	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; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
PLACEBO_COMPARATOR: Arm 5	Drug: Placebo; 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
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; Drug: Ibuprofen; Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
ACTIVE_COMPARATOR: Arm 4	Drug: Ibuprofen; Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid; Drug: Ibuprofen; Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication	2 hours post dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Study Completion (ACTUAL): August 1, 2004

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (ESTIMATE): November 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 25, 2014
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Ibuprofen
• Other Study ID Numbers: 11220 (Registry Identifier: DAIDS-ES)