A Safety Study Of Pregabalin In Fibromyalgia

NCT ID: NCT00282997

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-10-31

Brief Summary

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To evaluate the safety of pregabalin in patients with fibromyalgia.

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

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must complete the double-blind study.

Exclusion Criteria

* Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.
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

Little Rock, Arkansas, United States

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Fresno, California, United States

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La Jolla, California, United States

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Northridge, California, United States

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Pismo Beach, California, United States

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Sacramento, California, United States

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San Diego, 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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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Melbourne, Florida, United States

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Ocala, Florida, United States

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Palm Harbor, Florida, United States

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Sunrise, 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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Dubuque, Iowa, United States

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Prairie Village, Kansas, United States

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Pratt, Kansas, United States

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Lexington, Kentucky, United States

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Kenner, Louisiana, United States

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Metairie, Louisiana, United States

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North Dartmouth, Massachusetts, United States

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Watertown, Massachusetts, United States

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Worcester, Massachusetts, United States

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Chaska, Minnesota, United States

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Saint Paul, Minnesota, 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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Morristown, New Jersey, United States

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Albany, New York, United States

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Endwell, New York, United States

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New York, New York, United States

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West Seneca, New York, United States

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Asheville, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, 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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Dayton, Ohio, United States

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Tulsa, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Goose Creek, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Summerville, South Carolina, United States

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Knoxville, Tennessee, United States

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Milan, Tennessee, United States

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Nashville, Tennessee, United States

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Bedford, Texas, United States

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Georgetown, Texas, United States

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Houston, Texas, United States

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Killeen, 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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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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Everett, Washington, United States

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Spokane, 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, 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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A0081078

Identifier Type: -

Identifier Source: org_study_id

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