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A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

NCT ID: NCT00357825

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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[S,S]-Reboxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
* At screening and randomization, patients must have a score of \>/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).

Exclusion Criteria

* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
* Patients with severe hepatic impairment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chandler, Arizona, United States

Site Status

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Auburn, California, United States

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Orangevale, California, United States

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Pismo Beach, California, United States

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Walnut Creek, California, United States

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Newark, Delaware, United States

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DeLand, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Gurnee, Illinois, United States

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Moline, Illinois, United States

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Indianapolis, Indiana, United States

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Pratt, Kansas, United States

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Lexington, Kentucky, United States

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Fall River, Massachusetts, United States

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Mansfield, Massachusetts, United States

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Wellesley Hills, Massachusetts, United States

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Worcester, Massachusetts, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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New York, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Altoona, Pennsylvania, United States

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Bensalem, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Myrtle Beach, South Carolina, United States

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Milan, Tennessee, United States

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Nashville, Tennessee, United States

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Georgetown, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, 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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Virginia Beach, Virginia, United States

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Everett, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Arnold LM, Chatamra K, Hirsch I, Stoker M. Safety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2010 Aug;32(9):1618-32. doi: 10.1016/j.clinthera.2010.08.003.

Reference Type DERIVED
PMID: 20974319 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061034&StudyName=A%20Trial%20Assessing%20The%20Effectiveness%20and%20Safety%20of%20%5BS%2CS%5D-Reboxetine%20in%20Patients%20With%20Fibromyalgia%0D

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6061034

Identifier Type: -

Identifier Source: org_study_id

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