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Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00424892
First Posted: January 22, 2007
Last Update Posted: December 6, 2007
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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.

Condition Intervention Phase
Fibromyalgia Drug: Desvenlafaxine Sustained Release Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.

Estimated Enrollment: 600
Study Completion Date: June 2007
Detailed Description:
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424892


  Show 59 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00424892     History of Changes
Other Study ID Numbers: 3151A4-330
First Submitted: January 18, 2007
First Posted: January 22, 2007
Last Update Posted: December 6, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs