Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome - Full Text View

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 II Phase III

MedlinePlus related topics:

Fibromyalgia

ChemIDplus related topics:

Desvenlafaxine Succinate Desvenlafaxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further study details as provided by Wyeth:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424892

Show 59 Study Locations

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Study ID Numbers:	3151A4-330
First Received:	January 18, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00424892
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

O-desmethylvenlafaxine

Myofascial Pain Syndromes

Fibromyalgia

Pain

Rheumatic Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Psychotropic Drugs

Central Nervous System Agents

Antidepressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00424892