ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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.
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®).
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 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.
Eligibility
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.
Locations and Contacts
Additional Information
Last updated: November 29, 2010
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