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

This study has been completed.
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00246168
First received: October 28, 2005
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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®).


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: tramadol hydrochloride + acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

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

Enrollment: 277
Study Completion Date: June 2005
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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246168

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00246168     History of Changes
Other Study ID Numbers: CR005929
Study First Received: October 28, 2005
Last Updated: November 29, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Rheumatoid arthritis
NSAID add-on therapy
tramadol
acetaminophen

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014