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:
Johnson & Johnson Taiwan Ltd
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
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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
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 21, 2013