Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Universidad de Granada
ClinicalTrials.gov Identifier:
NCT00791739
First received: November 12, 2008
Last updated: January 10, 2011
Last verified: October 2010

November 12, 2008
January 10, 2011
April 2008
July 2009   (final data collection date for primary outcome measure)
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791739 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Baseline, 6, 12, 18, and 24 weeks ] [ Designated as safety issue: No ]
  • Discontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events [ Time Frame: baseline, 6, 12, 18, and 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
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)

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Drug: trazodone, pregabalin
  • phase I (from baseline to week 12): trazodone, in a starting dose of 50 mg at bedtime subsequently adjusted according to drug's efficacy and tolerability
  • phase II (from week 12 to week 24): addition of pregabalin in a starting dose of 75 mg/day subsequently adjusted according to drug's efficacy and tolerability
Other Names:
  • Deprax
  • Lyrica
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
October 2009
July 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00791739
TZD-PGB-2008
No
Elena Pita Calandre, Universidad de Granada
Universidad de Granada
Not Provided
Principal Investigator: Elena P Calandre, MD Universidad de Granada
Universidad de Granada
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP