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A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

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NCT00696787

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Huntsville, Alabama, 35801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00696787
Pfizer
Terminated
A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

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A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Desvenlafaxine Sustained Release (DVS SR)
  • Drug: Lyrica® (Pregabalin)
  • Drug: Placebo
  • Placebo Comparator: Placebo
    In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
    Intervention: Drug: Placebo
  • Experimental: DVS SR
    In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
    Intervention: Drug: Desvenlafaxine Sustained Release (DVS SR)
  • Active Comparator: Pregabalin
    In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
    Intervention: Drug: Lyrica® (Pregabalin)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
125
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00696787
3151A4-2003
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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