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Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791739
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 14, 2008
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
Official Title  ICMJE 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)
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: one arm study
Intervention: Drug: trazodone, pregabalin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2011)
66
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2008)
75
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791739
Other Study ID Numbers  ICMJE TZD-PGB-2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elena Pita Calandre, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elena P Calandre, MD Universidad de Granada
PRS Account Universidad de Granada
Verification Date December 2014

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