drugset / Trial / NCT00766402
An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram \[mg\]) in the treatment of pain in participants with ankylosing spondylitis (inflammation of the spine causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).
Timeline
- Start
- 2008-09-01
- Primary completion
- 2009-02-17
- Completion
- 2009-03-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | Oral |
| Comparator | Diclofenac | Other / unclassified | 50 mg | Oral |
| Subject | Tramadol | Other / unclassified | 37.5 mg | Oral |