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

Raynaud's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048763
• Other study ID #: 21-01-335
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2002
• Last updated: July 14, 2005
• Start date: October 2001
• Est. completion date: June 2003

Study information

• Verified date: July 2005
• Source: Otsuka America Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

Inclusion critera:

• 5 to 6 years old

• fulfill diagnostic criteria for primary or secondary Raynaud's

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Disease

Intervention

Drug:
• Pletal

Locations

Country	Name	City	State
United States	Advanced Medical Clinical Therapeutics	Anchorage	Alaska
United States	Children's Hospital Boston	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Children's Hospital of Buffalo	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	LaRabida Children's Hospital	Chicago	Illinois
United States	Advanced Medical Research Institute	Fresno	California
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	The Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Madera Family Medical Group	Madera	California
United States	Schneider Children's Hospital	New Hyde Park	New York
United States	Asthma & Allergy Research Center	Newark	New Jersey
United States	Monarch Research Associates	Norfolk	Virginia
United States	Children's Hospital	Omaha	Nebraska
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	St. Louis University Health Sciences Center	St. Louis	Missouri
United States	Jobst Vascular Center	Toledo	Ohio
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States,