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

NCT ID: NCT00696787

Last Updated: 2013-02-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-01-31

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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Desvenlafaxine Sustained Release (DVS SR)

Intervention Type DRUG

Pregabalin

In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.

Group Type ACTIVE_COMPARATOR

Lyrica® (Pregabalin)

Intervention Type DRUG

Interventions

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Desvenlafaxine Sustained Release (DVS SR)

Intervention Type DRUG

Lyrica® (Pregabalin)

Intervention Type DRUG

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Huntsville, Alabama, United States

Site Status

Roseville, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

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Santa Ana, California, United States

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Walnut Creek, California, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Rockville, Maryland, United States

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Lansing, Michigan, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Middleton, Wisconsin, United States

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Countries

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United States

Other Identifiers

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3151A4-2003

Identifier Type: -

Identifier Source: org_study_id

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