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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 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2014-10-15

No results posted yet for this study

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).

Conditions

  • Spondylitis, Ankylosing
  • Pain

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 & Collaborators

  • Johnson & Johnson Taiwan Ltd

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Taiwan, Ltd. Clinical Trial · Johnson & Johnson Taiwan Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-02-28
Completion
2009-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766402 on ClinicalTrials.gov