Status:
COMPLETED
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
Lead Sponsor:
Sosei
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in...
Eligibility Criteria
Inclusion
- Female
- Age 18-65
- Meet ACR 1990 criteria for classification of Fibromyalgia
- Able and willing to discontinue CNS active therapies
Exclusion
- If pain is NOT primarily due to Fibromyalgia
- Current or prior history of serious psychiatric disorder
- Pregnant/breastfeeding
- QTc \> 470ms
- Failure to respond to 2 or more adequate regimes of different classes of antidepressants.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00377039
Start Date
August 1 2006
End Date
August 1 2007
Last Update
October 2 2007
Active Locations (1)
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1
David L Scott
London, United Kingdom