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

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

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Desvenlafaxine

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	3151A4-330
Study First Received:	January 18, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00424892 History of Changes
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:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Nervous System Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 02, 2009