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)

PHASE4TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

February 28, 2009

Study Completion Date

March 31, 2009

Conditions
Spondylitis, AnkylosingPain
Interventions
DRUG

Tramadol /acetaminophen

Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.

DRUG

Diclofenac

Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.

Sponsors
All Listed Sponsors
lead

Johnson & Johnson Taiwan Ltd

INDUSTRY