Back to resultsSafety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Primary Purpose
Raynaud's Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pletal
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud's Disease focused on measuring circulatory, vascular, idiopathic
Eligibility Criteria
Inclusion critera: 5 to 6 years old fulfill diagnostic criteria for primary or secondary Raynaud's
Sites / Locations
- Advanced Medical Clinical Therapeutics
- Advanced Medical Research Institute
- Madera Family Medical Group
- Connecticut Children's Medical Center
- LaRabida Children's Hospital
- Children's Hospital Boston
- St. Louis University Health Sciences Center
- Children's Hospital
- Asthma & Allergy Research Center
- SUNY Downstate Medical Center
- Children's Hospital of Buffalo
- Schneider Children's Hospital
- New York Medical College
- Jobst Vascular Center
- The Milton S. Hershey Medical Center
- Medical University of South Carolina
- Monarch Research Associates
- Children's Hospital and Regional Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00048763
First Posted
November 7, 2002
Last Updated
July 14, 2005
Sponsor
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00048763
Brief Title
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Disease
Keywords
circulatory, vascular, idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pletal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion critera:
5 to 6 years old
fulfill diagnostic criteria for primary or secondary Raynaud's
Facility Information:
Facility Name
Advanced Medical Clinical Therapeutics
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Advanced Medical Research Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
LaRabida Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60649
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Asthma & Allergy Research Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Jobst Vascular Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
The Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Monarch Research Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Children's Hospital and Regional Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
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