Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Completed · Phase 3

Conditions studied: Fibromyalgia

In brief

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

Key facts

Study ID

NCT00797797

Run by

Forest Laboratories

People needed

364

Starts

2008-11-01

Expected to finish

2010-01-01

Last updated by the study team

2011-02-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site — Mesa, Arizona, United States
• Forest Investigative Site — Peoria, Arizona, United States
• Forest Investigative Site — Hot Springs, Arkansas, United States
• Forest Investigative Site — Anaheim, California, United States
• Forest Investigative Site — Sacramento, California, United States
• Forest Investigative Site — Sacramento, California, United States
• Forest Investigative Site — Torrance, California, United States
• Forest Investigative Site — Walnut Creek, California, United States
• Forest Investigative Site — Denver, Colorado, United States
• Forest Investigative Site — Cromwell, Connecticut, United States
• Forest Investigative Site — Danbury, Connecticut, United States
• Forest Investigative Site — Clearwater, Florida, United States
• Forest Investigative Site — Daytona Beach, Florida, United States
• Forest Investigative Site — Delray Beach, Florida, United States
• Forest Investigative Site — Fort Myers, Florida, United States
• Forest Investigative Site — Jacksonville, Florida, United States
• Forest Investigative Site — Miami, Florida, United States
• Forest Investigative Site — Ocala, Florida, United States
• Forest Investigative Site Orl2 — Orlando, Florida, United States
• Forest Investigative Site — Orlando, Florida, United States
• Forest Investigative Site — Ormond Beach, Florida, United States
• Forest Investigative Site PP1 — Pembroke Pines, Florida, United States
• Forest Investigative Site PP2 — Pembroke Pines, Florida, United States
• Forest Investigative Site — Pismo Beach, Florida, United States
• Forest Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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