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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the study medication) by comparing it to placebo (the control group without active substance) or 400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of back pain. The study is designed to develop a treatment method against back pain which will have more advantages for patients than the methods that are currently available.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Aspirin; Ibuprofen

Criteria

Inclusion Criteria:

• Ambulatory male or female, 18 to 70 years of age

• Body mass index ranging in-between 18 and 30 kg/m²

• Normal blood pressure

• Patients suffering from low back pain

• Low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain

Exclusion Criteria:

• Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal Anti-inflammatory drugs

• Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease

• Pregnancy or lactation period

• Abuse of alcohol or addictive substances