Status:
COMPLETED
A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
Lead Sponsor:
Pfizer
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00357825
Start Date
August 1 2006
End Date
March 1 2007
Last Update
May 15 2013
Active Locations (61)
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1
Pfizer Investigational Site
Chandler, Arizona, United States, 85225
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85007
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
4
Pfizer Investigational Site
Sun City, Arizona, United States, 85351