Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

NCT ID: NCT00797797

Last Updated: 2011-02-16

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-01-31

Brief Summary

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To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people 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

NONE

Study Groups

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Milnacipran Added

Group Type EXPERIMENTAL

Milnacipran Added

Intervention Type DRUG

Milnacipran 100 mg/d added

No Treatment Added

Group Type EXPERIMENTAL

No Treatment Added

Intervention Type DRUG

No added treatment

Interventions

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No Treatment Added

No added treatment

Intervention Type DRUG

Milnacipran Added

Milnacipran 100 mg/d added

Intervention Type DRUG

Other Intervention Names

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Lyrica (r)

Eligibility Criteria

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Inclusion Criteria

* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
* tolerate at least 300 mg/day of pregabalin
* have an incomplete response to pregabalin treatment

Exclusion Criteria

* suicidal risk
* substance abuse
* pulmonary dysfunction
* renal impairment
* active cardiac disease
* liver disease
* narrow angle glaucoma
* autoimmune disease
* cancer
* inflammatory bowel disease
* unstable endocrine disease
* prostatic enlargement
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)

Principal Investigators

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Patricia D'Astoli

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Locations

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Forest Investigative Site

Birmingham, Alabama, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Hot Springs, Arkansas, United States

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Anaheim, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Cromwell, Connecticut, United States

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Danbury, Connecticut, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Delray Beach, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Forest Investigative Site Orl2

Orlando, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Forest Investigative Site PP1

Pembroke Pines, Florida, United States

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Forest Investigative Site PP2

Pembroke Pines, Florida, United States

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Pismo Beach, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Couer D'Alene, Idaho, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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No. Dartmouth, Massachusetts, United States

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Worcester, Massachusetts, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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Syracuse, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, 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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Greer, South Carolina, United States

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Memphis, Tennessee, 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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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Woodstock, Vermont, United States

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Bellevue, Washington, United States

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Bellingham, Washington, United States

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Forest Investigative Site SEA1

Seattle, Washington, United States

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Forest Investigative Site SEA2

Seattle, Washington, United States

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Forest Investigative Site

Spokane, Washington, United States

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Forest Investigative Site

Racine, Wisconsin, United States

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Countries

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United States

Other Identifiers

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MLN-MD-15

Identifier Type: -

Identifier Source: org_study_id

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