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

NCT01464983 | Completed Phase 4

• 1 other identifier: 11220
• Study Type: interventional
• Target: 1,115
• Locations: 1 country
• Sites: 11

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.

Conditions

Headache; Tension-Type Headache; Tension-Type Headache (Episodic)

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication

  2 hours post dose

Secondary Outcomes (4)

• 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

Study Arms (5)

Arm 1

ACTIVE COMPARATOR

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 2

EXPERIMENTAL

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 3

ACTIVE COMPARATOR

Drug: Ibuprofen

Arm 4

ACTIVE COMPARATOR

Drug: Ibuprofen

Arm 5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465) DRUG

Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen

Arm 1

Ibuprofen DRUG

Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid

Arm 3

Placebo DRUG

2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose

Arm 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (11)

Unknown Facility

Reading, Berkshire, RG2 7AG, United Kingdom

Location

Unknown Facility

Manchester, Greater Manchester, M15 6SX, United Kingdom

Location

Unknown Facility

Chorley, Lancashire, PR7 1NY, United Kingdom

Location

Unknown Facility

Wigan, Lancashire, WN6 9EW, United Kingdom

Location

Unknown Facility

Liverpool, Merseyside, L1 9AD, United Kingdom

Location

Unknown Facility

Liverpool, Merseyside, L22 0LG, United Kingdom

Location

Unknown Facility

Cardiff, South Glamorgan, CF14 5GJ, United Kingdom

Location

Unknown Facility

Glasgow, Strathclyde, G81 2DR, United Kingdom

Location

Unknown Facility

Birmingham, West Midlands, B15 2SQ, United Kingdom

Location

Unknown Facility

Coventry, West Midlands, CV1 2TZ, United Kingdom

Location

Unknown Facility

Wolverhampton, West Midlands, WV10 9RU, United Kingdom

Location

MeSH Terms

Conditions

Headache; Tension-Type Headache; Recurrence

Interventions

Aspirin; Ibuprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: November 4, 2011
• Study Start: January 1, 2004
• Study Completion: August 1, 2004
• Last Updated: December 25, 2014

Record last verified: 2014-12

Locations

GB (11)