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

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: tramadol hydrochloride + acetaminophen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea

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®).

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Average daily pain relief score

Secondary outcome: 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

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.

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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

Starting date: November 2003
Ending date: June 2005
Last updated: October 19, 2007