Phase 4Terminated
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)
A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet®) vs. Diclofenac (Voltaren®) in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
- Sponsor
- Johnson & Johnson Taiwan Ltd (Industry)
- Enrollment
- 8 enrolled
- Conditions
- Spondylitis, Ankylosing; Pain
- Interventions
- Tramadol /acetaminophen; Diclofenac
- Ages
- adults, older adults
- Registry
- NCT00766402
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Change From Baseline in Visual Analogue Scale (VAS) Score at Week 2
- Change From Baseline in Visual Analogue Scale (VAS) Score at Week 4
- Change From Baseline in Visual Analogue Scale (VAS) Score at Week 8
History
Last registry update
Study completion
Primary completion
Registered
Started