Fibromyalgia Clinical Trial
Official title:
A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
NCT number | NCT00314249 |
Other study ID # | MLN-MD-03 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | April 11, 2006 |
Last updated | January 14, 2010 |
Start date | April 2006 |
Verified date | January 2010 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.
Status | Completed |
Enrollment | 1025 |
Est. completion date | |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: - psychiatric illness, - depression, - suicidal risk, - substance abuse, - pulmonary dysfunction, - renal impairment, - active cardiac disease, - liver disease, - autoimmune disease, - cancer, - inflammatory bowel disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site | Anderson | South Carolina |
United States | Forest Investigative Site | Atlanta | Georgia |
United States | Forest Investigative Site | Cleveland | Ohio |
United States | Forest Investigative Site | Columbus | Ohio |
United States | Forest Investigative Site | Eugene | Oregon |
United States | Forest Investigative Site | Fresno | California |
United States | Forest Investigative Site | Greensboro | North Carolina |
United States | Forest Investigative Site | Greer | South Carolina |
United States | Forest Investigative Site | Haddon Heights | New Jersey |
United States | Forest Investigative Site | Johnson City | New York |
United States | Forest Investigative Site | Mechanicsburg | Pennsylvania |
United States | Forest Investigative Site | Omaha | Nebraska |
United States | Forest Investigative Site | Pismo Beach | California |
United States | Forest Investigative Site | Richardson | Texas |
United States | Forest Investigative Site | Springfield | Massachusetts |
United States | Forest Investigative Site | St. Petersburg | Florida |
United States | Forest Investigative Site | St. Petersburg | Florida |
United States | Forest Investigative Site | Stuart | Florida |
United States | Forest Investigative Site | Syracuse | New York |
United States | Forest Investigative Site | Toledo | Ohio |
United States | Forest Investigative Site | Tuscaloosa | Alabama |
United States | Forest Investigative Site | Virginia Beach | Virginia |
United States | Forest Investigative Site | Vista | California |
United States | Forest Investigative Site | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | Cypress Bioscience, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Syndrome Responder Status | At the end of the three-month stable dose treatment phase | No | |
Primary | Composite Pain Responder Status | At the end of three-month stable dose treatment phase | No | |
Secondary | Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase | Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) | No | |
Secondary | Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | No | |
Secondary | Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. | Baseline through end of week 12 (Visit TX12) | No | |
Secondary | Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | No |
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