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TERMINATED
NCT00766402
PHASE4

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)

Sponsor: Johnson & Johnson Taiwan Ltd

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2008-09-01

Completion Date

2009-03-26

Last Updated

2026-06-04

Healthy Volunteers

No

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.

Locations (1)

Johnson & Johnson Taiwan Ltd.

Taipei, Taiwan