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
  Purpose

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.


Condition Intervention Phase
Raynaud's Disease
Drug: Pletal
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Otsuka America Pharmaceutical:

Estimated Enrollment: 75
Study Start Date: October 2001
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion critera:

  • 5 to 6 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048763

Locations
United States, Alaska
Advanced Medical Clinical Therapeutics
Anchorage, Alaska, United States, 99508
United States, California
Advanced Medical Research Institute
Fresno, California, United States, 93710
Madera Family Medical Group
Madera, California, United States, 93637
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Illinois
LaRabida Children's Hospital
Chicago, Illinois, United States, 60649
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis University Health Sciences Center
St. Louis, Missouri, United States, 63104
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114
United States, New Jersey
Asthma & Allergy Research Center
Newark, New Jersey, United States, 07103
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Pennsylvania
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Monarch Research Associates
Norfolk, Virginia, United States, 23510
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Otsuka America Pharmaceutical
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048763     History of Changes
Other Study ID Numbers: 21-01-335
Study First Received: November 7, 2002
Last Updated: July 14, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka America Pharmaceutical:
circulatory
vascular
idiopathic

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014