Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
- Conditions
- Raynaud's Disease
- Registration Number
- NCT00048763
- Lead Sponsor
- Otsuka America Pharmaceutical
- Brief Summary
Juvenile primary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud's Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud's Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynaud's episodes in juvenile patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
The Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
LaRabida Children's Hospital
🇺🇸Chicago, Illinois, United States
Advanced Medical Clinical Therapeutics
🇺🇸Anchorage, Alaska, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Children's Hospital and Regional Medical Center
🇺🇸Seattle, Washington, United States
St. Louis University Health Sciences Center
🇺🇸St. Louis, Missouri, United States
Children's Hospital
🇺🇸Omaha, Nebraska, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Asthma & Allergy Research Center
🇺🇸Newark, New Jersey, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Jobst Vascular Center
🇺🇸Toledo, Ohio, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Monarch Research Associates
🇺🇸Norfolk, Virginia, United States
Advanced Medical Research Institute
🇺🇸Fresno, California, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States