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

PHASE4CompletedINTERVENTIONAL
Enrollment

1,115

Participants

Timeline

Start Date

January 31, 2004

Study Completion Date

August 31, 2004

Conditions
HeadacheTension-Type HeadacheTension-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

Trial Locations (11)

RG2 7AG

Reading

M15 6SX

Manchester

PR7 1NY

Chorley

WN6 9EW

Wigan

L1 9AD

Liverpool

L22 0LG

Liverpool

CF14 5GJ

Cardiff

G81 2DR

Glasgow

B15 2SQ

Birmingham

CV1 2TZ

Coventry

WV10 9RU

Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY