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

This study has been completed.

Sponsor:

Information provided by:

Otsuka America Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00048763

First received: November 7, 2002

Last updated: July 14, 2005

Last verified: July 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	November 7, 2002
Last Updated Date	July 14, 2005
Start Date ^ICMJE	October 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00048763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Raynaud's Disease
Intervention ^ICMJE	Drug: Pletal
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	June 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00048763
Other Study ID Numbers ^ICMJE	21-01-335
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Otsuka America Pharmaceutical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka America Pharmaceutical
Verification Date	July 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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