drugset / Trial / NCT00647517

Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis

NCT00647517

Phase 4 Completed 60 enrolled Chung Shan Medical University
RandomizedParallel-groupTriple-blindHealth-services research

Summary

Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain (6).There is no clinical trial regarding tramadol usage in chronic inflammatory arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.

Timeline

Start
2008-03
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg
Subject Tramadol Other / unclassified 37.5 mg
Background Aceclofenac Small molecule 100 mg Oral