Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

Phase 2

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00424892
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Timeline

• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Study First Posted: 2007-01-22
• Study Completion: 2007-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-04
• Last Update Posted: 2007-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.