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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Acetaminophen; Tramadol

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.