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)

NCT00766402

Phase 4 Terminated 8 enrolled Johnson & Johnson Taiwan Ltd
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

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg Oral
Comparator Diclofenac Other / unclassified 50 mg Oral
Subject Tramadol Other / unclassified 37.5 mg Oral