A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
Phase 2
Completed
- Conditions
- Pain
- Registration Number
- NCT00357825
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
Inclusion Criteria
- At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
- At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
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Exclusion Criteria
- Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
- Patients with severe hepatic impairment.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weekly Average Pain Score from the Daily Pain Diary.
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scales (HADS) Fibromyalgia Impact Questionnaire (FIQ) Total Score Patient Global Impression of Change Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) Short-Form McGill Pain Questionnaire (SF-MPQ) Exposure Response Relationship Between Daily Dose and Daily Pain Score Short-Form 36 Health Survey (SF 36) Sheehan Disability Scale Quality of Sleep Score from the Daily Sleep Diary Multidimensional Assessment of Fatigue (MAF) Safety and Tolerability Fibromyalgia Health Assessment Questionnaire (F-HAQ)
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Milwaukee, Wisconsin, United States