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

NCT01464983 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1115

Last updated 2014-12-25

No results posted yet for this study

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)

Interventions

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

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2004-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464983 on ClinicalTrials.gov