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

Phase 2
Terminated
Conditions
Fibromyalgia
Interventions
Registration Number
NCT00696787
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
125
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboIn the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
DVS SRDesvenlafaxine Sustained Release (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.
PregabalinLyrica® (Pregabalin)In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Primary Outcome Measures
NameTimeMethod
Change From Baseline on the Numeric Rating Scale (NRS)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 Outcome Measures
NameTimeMethod
Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female OutpatientsBaseline and 8 weeks

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.

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