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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

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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.




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