Status:
COMPLETED
ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
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 non...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00246168
End Date
June 1 2005
Last Update
November 30 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.