A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Fibromyalgia
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 125
- Primary Endpoint
- Change From Baseline on the Numeric Rating Scale (NRS)
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Arms & Interventions
Placebo
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
Intervention: Placebo
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: Desvenlafaxine Sustained Release (DVS SR)
Pregabalin
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Intervention: Lyrica® (Pregabalin)
Outcomes
Primary Outcomes
Change From Baseline on the Numeric Rating Scale (NRS)
Time Frame: Baseline and 8 weeks
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 Outcomes
- Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients(Baseline and 8 weeks)