Back to resultsA Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Desvenlafaxine Sustained Release (DVS SR)
Lyrica® (Pregabalin)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria
Exclusion Criteria:
- Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
- Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
- Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Placebo
DVS SR
Pregabalin
Arm Description
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Outcomes
Primary Outcome Measures
Change From Baseline on the Numeric Rating Scale (NRS)
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Secondary Outcome Measures
Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Full Information
NCT ID
NCT00696787
First Posted
June 11, 2008
Last Updated
February 20, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00696787
Brief Title
A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.
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
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
Arm Title
DVS SR
Arm Type
Experimental
Arm Description
In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Sustained Release (DVS SR)
Intervention Type
Drug
Intervention Name(s)
Lyrica® (Pregabalin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline on the Numeric Rating Scale (NRS)
Description
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
Description
The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria
Exclusion Criteria:
Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
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
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92128
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
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
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
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
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
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
We'll reach out to this number within 24 hrs