This Open-label Study Will Evaluate the Analgesic Effectiveness and Safety Measurement of Tramadol HCl/Acetaminophen in the Treatment of Pain for Fibromyalgia.
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.
|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|
- Difference of the Pain Visual Analog Scale (VAS) at day 1, 14, 28 and 56.
- 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.
|Study Start Date:||May 2008|
|Study Completion Date:||March 2009|