Clinical Trial: Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Otsuka America Pharmaceutical

Current Primary Outcome:

Original Primary Outcome:

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Original Secondary Outcome:

Information By: Otsuka America Pharmaceutical

Dates:
Date Received: November 7, 2002
Date Started: October 2001
Date Completion: June 2003
Last Updated: July 14, 2005
Last Verified: July 2005