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Trial record 1 of 1 for:    NCT00424892
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Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT00424892
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 18, 2007
First Posted Date  ICMJE January 22, 2007
Last Update Posted Date December 6, 2007
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00424892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
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 Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
Official Title  ICMJE A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
Brief Summary 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.
Detailed Description Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: Desvenlafaxine Sustained Release
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: January 18, 2007)
600
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424892
Other Study ID Numbers  ICMJE 3151A4-330
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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