This Open-label Study Will Evaluate the Analgesic Effectiveness and Safety Measurement of Tramadol HCl/Acetaminophen in the Treatment of Pain for Fibromyalgia.

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00766675
First received: October 3, 2008
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

The purpose of the study is to evaluate the analgesic effectiveness and safety measurement of Ultracet in the treatment of pain for fibromyalgia. This is a multicenter, single arm study. Patients receiving antidepressants, cyclobenzaprine or anti-epileptic drugs for pain prior to entering this study, must discontinue these medications at least three weeks before entering the Treatment Phase.


Condition Intervention Phase
Pain
Fibromyalgia
Drug: Ultracet (tramadol HCL/acetaminophen)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultracet in the Treatment of the Pain of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • Difference of the Pain Visual Analog Scale (VAS) at day 1, 14, 28 and 56.

Secondary Outcome Measures:
  • The number of discontinuations due to lack of efficacy after the sixth day of the Treatment Phase; Pain Assessments (pain relief scores and tender-point evaluation/myalgic scores); and safety at Day 1, 14, 28 and 56.

Enrollment: 82
Study Start Date: May 2008
Study Completion Date: March 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
  • Patients must have had widespread pain (pain in three quadrants and in the axial skeleton) for at least three months
  • Patients must have pain on digital palpation in 11 or more of the 18 tender-point sites

Exclusion Criteria:

  • Patients who previously failed tramadol HCl therapy or those who discontinued tramadol HCl due to adverse events
  • Patients who have any of the following: active connective tissue or musculo-skeletal diseases (e.g., SLE or RA). Non-active SLE or RA patients will be permitted to enter the study. painful, symptomatic osteoarthritis which requires treatment with pain medication. Regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease
  • Patients who currently have more severe pain than the pain of fibromyalgia
  • Patients who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase
  • Patients who have taken short-acting analgesics, topical medications and anesthetics and/or muscle relaxants for a period of less than 21 days of the given medication prior to the Treatment Phase
  • Patients who have started to use nutriceuticals (e.g. glucosamine) within four weeks prior to the Treatment Phase
  • Patients who have received tender-point injections of local anesthetics within the last two months
  • Patients with a significant major psychiatric disorder (e.g. major depression) or subjects receiving anti-psychotic medication
  • Patients with a history of estimated creatinine clearance of < 30 mL/min
  • Patients receiving acupuncture within three weeks prior to the Treatment Phase
  • Patients who have epilepsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766675

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00766675     History of Changes
Other Study ID Numbers: CR015319
Study First Received: October 3, 2008
Last Updated: April 22, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:
Pain
Fibromyalgia
Ultracet
tramadol HCL/acetaminophen

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous 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 May 23, 2013