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Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Desvenlafaxine Sustained Release
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

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.

Full Information

First Posted
January 18, 2007
Last Updated
December 4, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00424892
Brief Title
Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
Official Title
A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Sustained Release
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

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