Status:
COMPLETED
Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
Lead Sponsor:
Universidad de Granada
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fib...
Eligibility Criteria
Inclusion
- patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria
- written, informed consent
- able to understand and comply with the requirements of the study
Exclusion
- pregnancy or breastfeeding
- unwillingness to discontinue other prescribed medications before entering in the study
- patients who had previously received trazodone without improvement or who did not tolerate the drug
- patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00791739
Start Date
April 1 2008
End Date
October 1 2009
Last Update
December 3 2014
Active Locations (1)
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1
Instituto de Neurociencias
Granada, Granada, Spain, 18012