Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

November 30, 2005

Study Completion Date

December 31, 2006

Conditions
Low Back Pain
Interventions
DRUG

Acetylsalicylic Acid (Aspirin, BAYE4465)

Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.

DRUG

Ibuprofen

Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.

DRUG

Placebo

Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.

Trial Locations (13)

20148

Hamburg

20459

Hamburg

21031

Hamburg

22177

Hamburg

30519

Hanover

33175

Bad Lippspringe

37574

Einbeck

59269

Beckum

94342

Straßkirchen

94550

Künzing

PL23 1DT

Fowey

PL12 6DL

Saltash

S3 9DA

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY