An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

NCT ID: NCT00151528

Last Updated: 2021-01-22

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

PHASE3

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-06-30

Brief Summary

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The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pregabalin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Los Alamitos, California, United States

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Newport Beach, California, United States

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Northridge, California, United States

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Pismo Beach, California, United States

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Redondo Beach, California, United States

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Riverside, California, United States

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Walnut Creek, California, United States

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Whittier, California, United States

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Danbury, Connecticut, United States

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New Milford, Connecticut, United States

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Stratford, Connecticut, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Palm Beach Gardens, Florida, United States

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Seminole, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Sunrise, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Oak Brook, Illinois, United States

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Peoria, Illinois, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Madisonville, Kentucky, United States

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New Orleans, Louisiana, United States

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Newton, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Lansing, Michigan, United States

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Kansas City, Missouri, United States

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Lebanon, New Hampshire, United States

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Princeton, New Jersey, United States

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Albany, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Wilmington, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Mogadore, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Mechanicsburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Lubbock, Texas, United States

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Richardson, 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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Woodstock, Vermont, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Yakima, Washington, United States

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Countries

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United States

References

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Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.

Reference Type DERIVED
PMID: 22503162 (View on PubMed)

Related Links

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Other Identifiers

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A0081057

Identifier Type: -

Identifier Source: org_study_id

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