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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: No Treatment Added (Drug); Milnacipran Added (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Patricia D'Astoli, Study Director, Affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Summary

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

Clinical Details

Official title: A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Global Impression of Change (PGIC) Responder Rate at End of Study

Secondary outcome: Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Forest Investigative Site, Birmingham, Alabama 35205, United States

Forest Investigative Site, Mesa, Arizona 85210, United States

Forest Investigative Site, Peoria, Arizona 85381, United States

Forest Investigative Site, Hot Springs, Arkansas 71913, United States

Forest Investigative Site, Anaheim, California 92801, United States

Forest Investigative Site, Sacramento, California 95821, United States

Forest Investigative Site, Sacramento, California 95825, United States

Forest Investigative Site, Torrance, California 90505, United States

Forest Investigative Site, Walnut Creek, California 94598, United States

Forest Investigative Site, Denver, Colorado 80239, United States

Forest Investigative Site, Cromwell, Connecticut 06416, United States

Forest Investigative Site, Danbury, Connecticut 06810, United States

Forest Investigative Site, Clearwater, Florida 33765, United States

Forest Investigative Site, Daytona Beach, Florida 32117, United States

Forest Investigative Site, Delray Beach, Florida 33484, United States

Forest Investigative Site, Fort Myers, Florida 33912, United States

Forest Investigative Site, Jacksonville, Florida 32216, United States

Forest Investigative Site, Miami, Florida 33169, United States

Forest Investigative Site, Ocala, Florida 34471, United States

Forest Investigative Site, Orlando, Florida 32806, United States

Forest Investigative Site Orl2, Orlando, Florida 32806, United States

Forest Investigative Site, Ormond Beach, Florida 32174, United States

Forest Investigative Site PP1, Pembroke Pines, Florida 33024, United States

Forest Investigative Site PP2, Pembroke Pines, Florida 33029, United States

Forest Investigative Site, Pismo Beach, Florida 93449, United States

Forest Investigative Site, St. Petersburg, Florida 33709, United States

Forest Investigative Site, Tampa, Florida 33614, United States

Forest Investigative Site, Atlanta, Georgia 30328, United States

Forest Investigative Site, Honolulu, Hawaii 96814, United States

Forest Investigative Site, Couer D'Alene, Idaho 83814, United States

Forest Investigative Site, Evansville, Indiana 47713, United States

Forest Investigative Site, Indianapolis, Indiana 46254, United States

Forest Investigative Site, Indianapolis, Indiana 46260, United States

Forest Investigative Site, Baltimore, Maryland 21208, United States

Forest Investigative Site, No. Dartmouth, Massachusetts 02747, United States

Forest Investigative Site, Worcester, Massachusetts 01610, United States

Forest Investigative Site, Jackson, Mississippi 39202, United States

Forest Investigative Site, St. Louis, Missouri 63141, United States

Forest Investigative Site, Omaha, Nebraska 68134, United States

Forest Investigative Site, Albuquerque, New Mexico 87108, United States

Forest Investigative Site, Syracuse, New York 13210, United States

Forest Investigative Site, Cincinnati, Ohio 45219, United States

Forest Investigative Site, Cleveland, Ohio 44122, United States

Forest Investigative Site, Eugene, Oregon 97404, United States

Forest Investigative Site, Medford, Oregon 97504, United States

Forest Investigative Site, Portland, Oregon 97210, United States

Forest Investigative Site, Greer, South Carolina 29651, United States

Forest Investigative Site, Memphis, Tennessee 38119, United States

Forest Investigative Site, Houston, Texas 77104, United States

Forest Investigative Site, Houston, Texas 77074, United States

Forest Investigative Site, Lake Jackson, Texas 77566, United States

Forest Investigative Site, Salt Lake City, Utah 84106, United States

Forest Investigative Site, Salt Lake City, Utah 84102, United States

Forest Investigative Site, Woodstock, Vermont 05091, United States

Forest Investigative Site, Bellevue, Washington 98004, United States

Forest Investigative Site, Bellingham, Washington 98226, United States

Forest Investigative Site SEA1, Seattle, Washington 98104, United States

Forest Investigative Site SEA2, Seattle, Washington 98104, United States

Forest Investigative Site, Spokane, Washington 99204, United States

Forest Investigative Site, Racine, Wisconsin 53406, United States

Additional Information

Starting date: November 2008
Last updated: January 20, 2011

Page last updated: August 23, 2015

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