A Controlled Pregabalin Trial In Fibromyalgia

NCT ID: NCT00230776

Last Updated: 2021-01-26

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

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-07-31

Brief Summary

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To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

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

Interventions

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pregabalin

Intervention Type DRUG

placebo

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 have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
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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Ocala, Florida, United States

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Palm Beach Gardens, 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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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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Morton Grove, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Dubuque, Iowa, 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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Lansing, Michigan, 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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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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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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Tulsa, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, 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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Chattanooga, Tennessee, 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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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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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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Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.

Reference Type DERIVED
PMID: 26694975 (View on PubMed)

Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.

Reference Type DERIVED
PMID: 21639874 (View on PubMed)

Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.

Reference Type DERIVED
PMID: 21039311 (View on PubMed)

Related Links

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Other Identifiers

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A0081077

Identifier Type: -

Identifier Source: org_study_id

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