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

Phase 2TerminatedNCT00696787

Wyeth is now a wholly owned subsidiary of Pfizer125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Fibromyalgia

Interventions

Desvenlafaxine Sustained Release (DVS SR)DRUG

Lyrica® (Pregabalin)DRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Unnamed facility

Huntsville, Alabama, United States

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 8 weeks

Secondary Outcomes

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.

Time frame: Baseline and 8 weeks

Data from ClinicalTrials.gov

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