ULTRACET® (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain. - Tabular View

Tracking Information

First Received Date ^ICMJE

October 28, 2005

Last Updated Date

October 19, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Average daily pain relief score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00246168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

ULTRACET® (Tramadol Hydrochloride and Acetaminophen) Add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-Blind, Placebo-Controlled Study

Brief Summary

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®).

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 rheumaoid 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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Arthritis, Rheumatoid

Intervention ^ICMJE

Drug: tramadol hydrochloride + acetaminophen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

188

Completion Date

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00246168

Responsible Party

Study ID Numbers ^ICMJE

CR005929

Study Sponsor ^ICMJE

Janssen Korea, Ltd., Korea

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Janssen Korea, Ltd. Clinical Trial

Janssen Korea, Ltd., Korea

Information Provided By

Janssen Korea, Ltd., Korea

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP