Clinical trial NCT00048776: Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Raynaud's Disease
Keywords: Secondary Raynaud's
circulatory
vascular
scleroderma
lupus
mixed connective tissue disease
Lead sponsor: Otsuka America Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2002-11-11
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria

* 5 to 16 years old
* fulfill diagnostic criteria for primary or secondary Raynaud's

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Advanced Medical Clinical Therapeutics
state: Alaska
city: Fresno
country: United States
facility: Advanced Medical Research Institute
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Chicago
country: United States
facility: LaRabida Children's Hospital
state: Illinois
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital
state: Nebraska
city: Newark
country: United States
facility: Asthma & Allergy Research Center
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Buffalo
country: United States
facility: Children's Hospital of Buffalo
state: New York
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Hershey
country: United States
facility: The Milton S. Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Norfolk
country: United States
facility: Monarch Research Associates
state: Virginia
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
References: