Clinical Trials Directory

Trials / Completed

CompletedNCT01464983

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
1,115 (actual)
Sponsor
Bayer · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGAcetylsalicylic 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
DRUGAcetylsalicylic acid (Aspirin, BAYE4465)Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
DRUGIbuprofenIbuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
DRUGIbuprofenIbuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
DRUGPlacebo2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose

Timeline

Start date
2004-01-01
Completion
2004-08-01
First posted
2011-11-04
Last updated
2014-12-25

Locations

11 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01464983. Inclusion in this directory is not an endorsement.