Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon - Tabular View

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

This study has been completed.

Study NCT00048763. Last updated on July 14, 2005. Information provided by Otsuka America Pharmaceutical

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
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 Description
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Raynaud's Disease
Intervention ^†	Drug: Pletal
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	75
Start Date ^†	October 2001
Completion Date	June 2003
Eligibility Criteria ^†	Inclusion critera: 5 to 6 years old fulfill diagnostic criteria for primary or secondary Raynaud's
Gender	Both
Ages	5 Years to 16 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00048763
Organization ID	21-01-335
Secondary IDs ^††
Study Sponsor ^†	Otsuka America Pharmaceutical
Collaborators ^††
Investigators ^†
Information Provided By	Otsuka America Pharmaceutical
Verification Date	July 2005
First Received Date ^†	November 7, 2002
Last Updated Date	July 14, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.