Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Condition(s) targeted: Fibromyalgia

Intervention: pregabalin (Drug); milnacipran (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Nooshine Dayani, PhD, MBA, Study Director, Affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Overall contact:
Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

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

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: PGIC responder rate at end of study

Secondary outcome: Change from baseline in VAS 1-week pain recall at end of study

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

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

Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

Forest Investigative Site, Birmingham, Alabama 35205, United States; Not yet recruiting

Forest Investigative Site, Mesa, Arizona 85210, United States; Not yet recruiting

Forest Investigative Site, Peoria, Arizona 85381, United States; Not yet recruiting

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

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

Forest Investigative Site, Sacramento, California 95825, United States; Recruiting

Forest Investigative Site, Torrance, California 90505, United States; Recruiting

Forest Investigative Site, Anaheim, California 92801, United States; Recruiting

Forest Investigative Site, Carmichael, California 95608, United States; Recruiting

Forest Investigative Site, Denver, Colorado 80212, United States; Not yet recruiting

Forest Investigative Site, Danbury, Connecticut 06810, United States; Recruiting

Forest Investigative Site, Cromwell, Connecticut 06416, United States; Recruiting

Forest Investigative Site, Daytona Beach, Florida 32117, United States; Not yet recruiting

Forest Investigative Site, Ocala, Florida 34471, United States; Recruiting

Forest Investigative Site, Orlando, Florida 32806, United States; Not yet recruiting

Forest Investigative Site, Miami, Florida 33169, United States; Recruiting

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

Forest Investigative Site, Clearwater, Florida 33765, United States; Recruiting

Forest Investigative Site, Jacksonville, Florida 32216, United States; Recruiting

Forest Investigative Site, Tampa, Florida 33614, United States; Recruiting

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

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

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

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

Forest Investigative Site, Ormond Beach, Florida 32174, United States; Not yet recruiting

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

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

Forest Investigative Site, Atlanta, Georgia 30328, United States; Recruiting

Forest Investigative Site, Honolulu, Hawaii 96814, United States; Recruiting

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

Forest Investigative Site, Evansville, Indiana 47713, United States; Recruiting

Forest Investigative Site, Indianapolis, Indiana 46260, United States; Not yet recruiting

Forest Investigative Site, Indianapolis, Indiana 46254, United States; Not yet recruiting

Forest Investigative Site, Baltimore, Maryland 21208, United States; Recruiting

Forest Investigative Site, Worcester, Massachusetts 01610, United States; Not yet recruiting

Forest Investigative Site, No. Dartmouth, Massachusetts 02747, United States; Not yet recruiting

Forest Investigative Site, Jackson, Mississippi 39202, United States; Not yet recruiting

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

Forest Investigative Site, Omaha, Nebraska 68134, United States; Not yet recruiting

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

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

Forest Investigative Site, Cleveland, Ohio 44122, United States; Recruiting

Forest Investigative Site, Cincinnati, Ohio 45219, United States; Not yet recruiting

Forest Investigative Site, Eugene, Oregon 97404, United States; Recruiting

Forest Investigative Site, Portland, Oregon 97210, United States; Recruiting

Forest Investigative Site, Medford, Oregon 97504, United States; Not yet recruiting

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

Forest Investigative Site, Memphis, Tennessee 38119, United States; Recruiting

Forest Investigative Site, Houston, Texas 77104, United States; Not yet recruiting

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

Forest Investigative Site, Houston, Texas 77074, United States; Not yet recruiting

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

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

Forest Investigative Site, Woodstock, Vermont 05091, United States; Recruiting

Forest Investigative Site, Spokane, Washington 99204, United States; Not yet recruiting

Forest Investigative Site, Bellingham, Washington 98226, United States; Not yet recruiting

Forest Investigative Site, Bellevue, Washington 98004, United States; Recruiting

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

Forest Investigative Site SEA2, Seattle, Washington 98104, United States; Not yet recruiting

Forest Investigative Site, Racine, Wisconsin 53406, United States; Not yet recruiting

Starting date: November 2008
Last updated: January 22, 2009