Fibromyalgia Clinical Trial
Official title:
Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)
Verified date | December 2014 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health and Consumption |
Study type | Interventional |
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 fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.
Status | Completed |
Enrollment | 66 |
Est. completion date | October 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Instituto de Neurociencias | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Morillas-Arques P, Rodriguez-Lopez CM, Molina-Barea R, Rico-Villademoros F, Calandre EP. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study. BMC Musculoskelet Disord. 2010 Sep 10;11:204. doi: 10.1186/1471-2474-11-204. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire | Baseline, 6, 12, 18 and 24 weeks | No | |
Secondary | Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression Scale | Baseline, 6, 12, 18, and 24 weeks | No | |
Secondary | Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events | baseline, 6, 12, 18, and 24 weeks | Yes |
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