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

July 14, 2005 updated by: Otsuka America Pharmaceutical
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion critera:

  • 5 to 6 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka America Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

November 7, 2002

First Submitted That Met QC Criteria

November 8, 2002

First Posted (Estimate)

November 11, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2005

Last Update Submitted That Met QC Criteria

July 14, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-01-335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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