Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00424892
First received: January 18, 2007
Last updated: December 4, 2007
Last verified: December 2007

January 18, 2007
December 4, 2007
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The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
Same as current
Complete list of historical versions of study NCT00424892 on ClinicalTrials.gov Archive Site
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
Same as current
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Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.

The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.

Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Drug: Desvenlafaxine Sustained Release
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
June 2007
Not Provided

Inclusion Criteria:

  • Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
  • Women of childbearing potential must have a negative serum pregnancy test result at study start.

Exclusion criteria:

  • Presence of any new/and or clinically important medical condition that might compromise patient's safety.
  • Use of prohibited treatment.
  • Meets any of the exclusion criteria listed for study 3151A4-327.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00424892
3151A4-330
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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