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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Desvenlafaxine Sustained Release (DVS SR)
* Drug: Lyrica® (Pregabalin)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. | Drug: Placebo<br> <br> |
| Experimental: DVS SR<br>In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. | Drug: Desvenlafaxine Sustained Release (DVS SR)<br> <br> |
| Active Comparator: Pregabalin<br>In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor. | Drug: Lyrica® (Pregabalin)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks |