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

Condition(s) targeted: Raynaud's Disease

Intervention: Pletal (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Otsuka America Pharmaceutical

Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud’s 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. 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 secondary Raynaud’s episodes in juvenile patients.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 5 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- 5 to 16 years old

- fulfill diagnostic criteria for primary or secondary Raynaud's

Advanced Medical Clinical Therapeutics, Anchorage, Alaska 99508, United States

Advanced Medical Research Institute, Fresno, California 93710, United States

Madera Family Medical Group, Madera, California 93637, United States

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States

LaRabida Children's Hospital, Chicago, Illinois 60649, United States

Children's Hospital Boston, Boston, Massachusetts 02115, United States

St. Louis University Health Sciences Center, St. Louis, Missouri 63104, United States

Children's Hospital, Omaha, Nebraska 68114, United States

Asthma & Allergy Research Center, Newark, New Jersey 07103, United States

Children's Hospital of Buffalo, Buffalo, New York 14222, United States

New York Medical College, Valhalla, New York 10595, United States

Schneider Children's Hospital, New Hyde Park, New York 11040, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Jobst Vascular Center, Toledo, Ohio 43606, United States

The Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Monarch Research Associates, Norfolk, Virginia 23510, United States

Children's Hospital and Regional Medical Center, Seattle, Washington 98105, United States

Starting date: October 2001
Ending date: June 2003
Last updated: July 14, 2005