Status:
COMPLETED
An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Pain
Fibromyalgia
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and...
Detailed Description
This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatm...
Eligibility Criteria
Inclusion
- Participants must meet the American College of Rheumatology 1990 criteria for the classification of fibromyalgia (that are, Participants must have had widespread pain \[pain in three quadrants and in the axial skeleton\] for at least three months and pain on digital palpation in 11 or more of the 18 tender-point sites
- Female participants must not be pregnant, breast feeding or postmenopausal for at least one year
- Participant must be able to take oral medication
- Participants must have completed the Screening or wash-out procedures and have a visual analog scale score greater than or equal to 40 milliliter
- Fail to non-opioid analgesics
Exclusion
- Participants who previously failed tramadol hydrochloride therapy or those who discontinued tramadol hydrochloride due to adverse events
- Participants diagnosed with either any active connective tissue or musculo-skeletal diseases, or malignancy or history of malignancy within past 5 years, or painful, symptomatic osteoarthritis, or regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease
- Participants who currently have more severe pain than the pain of fibromyalgia
- Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase
- Participants 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00766675
Start Date
October 1 2008
End Date
April 1 2009
Last Update
July 3 2013
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