MedTrace Logo

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

NCT00647517 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-04-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ultracet

For the treatment arm: Tramadol 37.5 mg/APAP 325 mg combination tablets (Ultracet®) one tablet twice a day plus aceclofenac tablet per oral 100 mg twice a day. For the control group: Placebo plus aceclofenac tablet per oral 100 mg twice a day.

Sponsors & Collaborators

  • Chung Shan Medical University

    lead OTHER

Principal Investigators

  • James WEI, MD, PhD. · Department of rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT00647517 on ClinicalTrials.gov