NCT00048763

Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: Otsuka America Pharmaceutical · Industry
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Raynaud's Disease

Interventions

Type	Name	Description
DRUG	Pletal

Timeline

• Start date: 2001-10-01
• Completion: 2003-06-01
• First posted: 2002-11-11
• Last updated: 2005-07-19

Locations

18 sites across 1 country: United States