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Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients Clinical research trials and Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients. Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients clinical trial. Test subjects typically receive the most effective healthcare possible for their Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
For Condition: Systemic Sclerosis,Scleroderma
Status: Recruiting
Sponsor(s): Actelion ,
Synopsis: To date, one clinical trial, RAPIDS-1, was performed in Scleroderma patients with or without digital ulcers at baseline. The RAPIDS-1 study results showed that Bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of this trial is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24 week treatment period.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Main Inclusion Criteria: - Systemic Sclerosis (SSc), diffuse or limited - SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer. Main Exclusion Criteria: - Digital ulcers due to conditions other than SSc. - Severe pulmonary arterial hypertension (PAH) (Who class III and IV). - Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life- threatening condition. - Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization. - Treatment with inhaled or oral prostanoids one month prior to randomization. - Previous treatment with bosentan.
Total Enrollment: 180
Location and Contact Information:
Mittie Doyle, MD *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Melanie Larrieu 504-587-7620
Bashar Kahaleh, MD *Recruiting*
Toledo, Ohio, 43614
United States
Recruiting Carol Albright 419-383-5299
Michael Ellman, MD *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Shahnaz Kazi 773-702-2645
Frederick Wigley, MD *Recruiting*
Baltimore, Maryland, 21224
United States
Recruiting Edrick Forbes 510-550-8582
Joseph Korn, MD *Recruiting*
Boston, Massachusetts, 02118-2394
United States
Recruiting Kimberly Tobin 617-638-7503
Richard Martin, MD *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Melissa VanDyken 616-459-8088
Thomas Medsger, MD *Not yet recruiting*
Pittsburgh, Pennsylvania, 15261
United States
Not yet recruiting Carol Blair 412-383-8672
Howard Kenney, MD *Recruiting*
Spokane, Washington, 99204
United States
Recruiting Chiara Reillo 509-838-6500
Daniel Furst, MD *Recruiting*
Los Angeles, California, 90095-1670
United States
Recruiting Tina Burger 310-825-3061
Edwin Smith, MD *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Katie Caldwell 843-792-2014
Jerry Molitor, MD *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Carey Edwards 206-223-6836
Avram Goldberg, MD *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Cerdi Beltre 516-562-3732
Lee Shapiro, MD *Recruiting*
Albany, New York, 12206
United States
Recruiting Christine Barr 518-533-1324
Barri Fessler, MD *Recruiting*
Birmingham, Alabama, 35249-7201
United States
Recruiting Paula McKenzie 205-934-2981
Vivien Hsu, MD *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Julianne Wilson 732-235-7862
Thomas Osborn, MD *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Jane Jaquith 507-284-4502
Mary Ellen Csuka, MD *Recruiting*
Milwaukee, Wisconsin, 53211
United States
Recruiting Jovanka Zrnic 414-456-7022
Chris Derk, MD *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting John Furlong 215-955-1266
Eric Rich, MD *Recruiting*
Montreal, Quebec, H2L 4M1
Canada
Recruiting Diane Therrien 514-890-8000
Peter Lee, MD *Not yet recruiting*
Toronto, Ontario, M5G 1X5
Canada
Not yet recruiting Judi Guthrie 416-586-8616
David Collier, MD *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Janice Wagner 720-848-1958
Janet Pope, MD *Recruiting*
London, Ontario, N6A 4V2
Canada
Recruiting Donna McBain 519-646-6000
Naomi Rothfield, MD *Recruiting*
Farmington, Connecticut, 06030-1310
United States
Recruiting Frances Ingenito 860-679-2589
Murray Baron, MD *Recruiting*
Montreal, Quebec, H3T1E2
Canada
Recruiting Maura Buchignani 514-340-8231
Maureen Mayes, MD *Recruiting*
Houston, Texas, 77030
United States
Recruiting Samantha Jordan 713-500-7118
Additional Information:
Study ID Numbers: RAPIDS-2 / AC-052-331;
Study Start Date: September 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077584
Other Scleroderma Studies:
1. Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
2. Psychological Treatments for Scleroderma
3. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
4. Scleroderma Registry
5. Stem Cell Transplant to Treat Patients with Systemic Sclerosis
Related Studies:
Other Scleroderma Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
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