Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424892
• Other study ID #: 3151A4-330
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 18, 2007
• Last updated: December 4, 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Desvenlafaxine Sustained Release

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.