Back to resultsULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tramadol hydrochloride + acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid arthritis, NSAID add-on therapy, tramadol, acetaminophen
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Average daily pain relief score
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00246168
First Posted
October 28, 2005
Last Updated
November 29, 2010
Sponsor
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT00246168
Brief Title
ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Janssen Korea, Ltd., Korea
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid arthritis, NSAID add-on therapy, tramadol, acetaminophen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tramadol hydrochloride + acetaminophen
Primary Outcome Measure Information:
Title
Average daily pain relief score
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Korea, Ltd. Clinical Trial
Organizational Affiliation
Janssen Korea, Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
We'll reach out to this number within 24 hrs