ULTRACET® (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain. - Full Text View

Sponsor:	Janssen Korea, Ltd., Korea
Information provided by:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00246168

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Tramadol Tramadol hydrochloride Acetaminophen CT 2584

U.S. FDA Resources

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

Estimated Enrollment:	188
Study Start Date:	November 2003
Estimated 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 rheumaoid 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., Korea

More Information

No publications provided

Study ID Numbers:	CR005929
Study First Received:	October 28, 2005
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00246168 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:

Rheumatoid arthritis
tramadol
NSAID add-on therapy
acetaminophen

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Tramadol
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010