Not Signed In -
Fibromyalgia |
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Clinical Trial: Study of Milnacipran for the Treatment of Fibromyalgia
This study is currently recruiting patients.
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Purpose
Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Fibromyalgia | Drug: milnacipran hydrochloride | Phase III |
MedlinePlus related topics: Fibromyalgia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
Further Study Details:
Primary Outcomes: Composite responder analysis based on pain, patient global status, and physical function.
Secondary Outcomes: Quality of Life; Health Assessment Questionnaire (HAQ) Disability Index; Fatigue, sleep and cognitive assesments
Expected Total Enrollment: 783
Secondary Outcomes: Quality of Life; Health Assessment Questionnaire (HAQ) Disability Index; Fatigue, sleep and cognitive assesments
Expected Total Enrollment: 783
Study start: November 2004
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
Criteria
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
- Sleep apnea
- Inflammatory bowel disease
Location and Contact Information
Alabama
Coastal Clinical Research, Mobile, Alabama, 36608, United States; Recruiting
Sherri Orso, CCRC 251-634-4534 sherrio@coastalclinicalresearch.com
Arizona
Pivotal Research Centers, Peoria, Arizona, 85381, United States; Recruiting
Tami Footer 623-815-9714 Ext. 251 tfooter@pivotalresearch.com
California
Balboa Medical Group, San Diego, California, 92117, United States; Recruiting
Shelly Van Brabant 858-292-0108 Ext. 207 shellyvanbrabant@yahoo.com
Colorado
Arthritis Associates & Osteoporosis Center of Colorado Springs, Colorado Springs, Colorado, 80910, United States; Recruiting
Debbie Spoerl 719-475-9616 debbiespoerl@msn.com
Connecticut
Stamford Therapeutics Consortium, Stamford, Connecticut, 06905, United States; Recruiting
Lana Koanqu 203-325-8529 judith1205@aol.com
Florida
The Arthritis Center, Palm Harbor, Florida, 34684, United States; Recruiting
Shonte Jones 727-789-2784 Ext. 12 ccrc11@aol.com
Tampa Bay Medical Research, Clearwater, Florida, 33761, United States; Recruiting
Bettie Carney, LPN, CCRC 727-724-3316 Ext. 106 tbmr@tbmr.net
Renstar Medical Research, Ocala, Florida, 34471, United States; Recruiting
Lynn Craggs 773-278-1567 lynncraggs@aol.com
Coastal Clinical Research, Port Orange, Florida, 32127, United States; Recruiting
Sandi Geyer 386-304-7070 Ext. 224 coastalmr1@aol.com
CLIRECO, Inc., Tamarac, Florida, 33321, United States; Recruiting
Robin Ramirez 954-724-3232 clireco@hotmail.com
University Clinical Research, Inc., Deland, Florida, 32720, United States; Recruiting
Alicia Cevera 386-740-0770 Ext. 328 dcasteel@ucrdeland.com
Medical Research Associates, LLC, Clearwater, Florida, 33761, United States; Recruiting
Beverly Reynolds 727-793-9500 mrabev@tampabay.rr.com
Jacksonville Center for Clinical Research, Jacksonville, Florida, 33216, United States; Recruiting
Amy A. Bush 904-732-6668 amyautrybush@jaxresearch.com
Georgia
Non-Surgical Orthopedic & Spine Center, PC, Marietta, Georgia, 30060, United States; Recruiting
Nancy Stevens, CCRC 770-421-2030 nstevens_1@hotmail.com
Idaho
St. Luke's Meridian Medical Center, Meridian, Idaho, 83642, United States; Recruiting
Stacie Rotzien 208-861-6848 stacierotzien@hotmail.com
Illinois
Lake County Research Association, Libertyville, Illinois, 60048, United States; Recruiting
Ellie Batson, CCRC 847-816-3084 elliebatson@msn.com
Indiana
Arnett Clinic - Department of Rheumatology, Lafayette, Indiana, 47904, United States; Recruiting
Gloria Fallon 765-448-8830 fallong@arnett.com
Kansas
Heartland Research Associates, Wichita, Kansas, 67207, United States; Recruiting
Terri Ford 316-689-6634 tford@heartlandresearch.com
Louisiana
Dolby Research, New Orleans, Louisiana, 70128, United States; Recruiting
Tasha Stevenson 504-244-4405 qstevenson@dolby22.com
Clinical Trials Management, LLC, Metairie, Louisiana, 70006, United States; Recruiting
Jeff Segner 504-455-1310 jsegner@noctm.com
Maryland
Columbia Medical Practice, Columbia, Maryland, 21045, United States; Recruiting
Geri Novak 410-997-5204 gln@rxtrialsinc.com
RW Marcus, MD, Baltimore, Maryland, 21237, United States; Recruiting
Ann Beezley 410-574-9090 abeezley@osteocenter.com
Massachusetts
Phase III Clinical Research, Fall River, Massachusetts, 02720, United States; Recruiting
Arlene Turgeon, CCRC 508-235-6468 arleneturgeon@yahoo.com
Infinity Medical Research, Swansea, Massachusetts, 02777, United States; Recruiting
Michelle Ketchum, CMA, CCRC 508-674-5995 mketchum@infinitymedicalresearch.com
Michigan
Westside Family Medical Center, P.C., Kalamazoo, Michigan, 49009, United States; Recruiting
Brad Allen 269-372-7458
New Mexico
Lovelace Scientific Resources - NM, Santa Fe, New Mexico, 87505, United States; Recruiting
Cindy Knott 505-982-0601 lereynolds@lrri.org
Oregon
The Portland Clinic, LLP, Portland, Oregon, 97205, United States; Recruiting
Nancy Chess, CCRC 503-221-0161 Ext. 2109 nchess@tpcllp.com
Pennsylvania
Altoona Center for Clinical Research, Duncanville, Pennsylvania, 16635, United States; Recruiting
Connie Stewart 814-693-0300 Ext. 191 lriley@alttonaresearch.com
Rhode Island
Omega Medical Research, Warwick, Rhode Island, 02886, United States; Recruiting
Joy Geer 401-739-9350 Ext. 16 omrtrials.aol.com
Texas
Benchmark Research, Austin, Texas, 78705, United States; Recruiting
Lisa Phillips 512-478-5416 lisaphillips@benchmarkresearch.net
Quality Research, Inc., San Antonio, Texas, 78209, United States; Recruiting
Ellen Spelman, LVN, CCRC 210-824-5678 qualityrsrch@yahoo.com
Benchmark Research, Fort Worth, Texas, 76135, United States; Recruiting
Ramona Irizarry 817-238-7254 ramonairizarry@benchmarkresearch.net
Virginia
East Coast Clinical Research, LLC, Virginia Beach, Virginia, 23454, United States; Recruiting
Lois Bosken, RN, BSN, CCRC 757-481-9406 Lorick2@pol.net
Washington
South Puget Sound Clinical Medical Center, Olympia, Washington, 98502, United States; Recruiting
Valerie Prietto 360-754-4724 aprietto@olywa.net
More Information
Study ID Numbers: MLN-MD-02
Record last reviewed: February 2005
Last Updated: February 15, 2005
Record first received: December 3, 2004
ClinicalTrials.gov Identifier: NCT00098124
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2005
Last Updated: February 15, 2005
Record first received: December 3, 2004
ClinicalTrials.gov Identifier: NCT00098124
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- A Physician's Guide to Fibromyalgia Syndrome (Missouri Arthritis Rehabilitation Research and Training Center)
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