ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.

November 29, 2010 updated by: Janssen Korea, Ltd., Korea

ULTRACET (Tramadol Hydrochloride and Acetaminophen) add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled Study

The purpose of this study is to assess the effectiveness of ULTRACET® (a combination analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. Advil®, Motrin® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g. Celebrex®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, multicenter, placebo-controlled, double-blind study to evaluate the efficacy and safety of ULTRACET® (tramadol 37.5 mg and acetaminophen 325 mg) as add-on therapy in rheumatoid arthritis patients taking an NSAID or a COX-2 inhibitor. The patients will be randomized into 2 treatment groups: The first group will receive one ULTRACET® tablet 3 times per day for 7 days. The second group will receive one placebo tablet 3 times per day for 7 days. The primary efficacy measurement will be the patients' average daily pain score. Safety will be monitored throughout the study. The study hypothesis is that ULTRACET® will be well tolerated and the average daily pain relief score for the ULTRACET® treatment group will be better than that of placebo group. Patients will take one ULTRACET® tablet or placebo by mouth 3 times per day, for 7 days.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with rheumatoid arthritis at least 6 months before the participation in the clinical trial, (defined by having more than 4 of the diagnosis criteria suggested by American College of Rheumatology (ACR
  • 1987))
  • have been on a stable daily dose of an NSAID or a COX-2 inhibitor for at least 30 days prior to the start of the study
  • have arthralgia (arthritis pain in the joints) for at least 2 days before the entering clinical trial, with a pain score on the Visual Analogue Scale (VAS) of 40 mm or greater.

Exclusion Criteria:

  • Have had an inadequate response to Tramadol HCl therapy, or have discontinued Tramadol HCl therapy due to adverse events
  • have taken Tramadol HCl within 30 days prior to study entry
  • have recently taken other medications for pain relief, (other than their daily NSAID or COX-2 inhibitor
  • daily use of aspirin at a dose greater than 100 mg per day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Average daily pain relief score

Secondary Outcome Measures

Outcome Measure
Average daily pain intensity score; average pain relief and intensity score for the final visit; patient's assessment of physical function; overall assessment by the patient; overall assessment by the investigator; and an evaluation of safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe