MedDataX Logo

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

NCT ID: NCT00048763

Last Updated: 2005-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2003-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Raynaud's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

circulatory vascular idiopathic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pletal

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 5 to 6 years old
* fulfill diagnostic criteria for primary or secondary Raynaud's
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advanced Medical Clinical Therapeutics

Anchorage, Alaska, United States

Site Status

Advanced Medical Research Institute

Fresno, California, United States

Site Status

Madera Family Medical Group

Madera, California, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

LaRabida Children's Hospital

Chicago, Illinois, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

Children's Hospital

Omaha, Nebraska, United States

Site Status

Asthma & Allergy Research Center

Newark, New Jersey, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Children's Hospital of Buffalo

Buffalo, New York, United States

Site Status

Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Jobst Vascular Center

Toledo, Ohio, United States

Site Status

The Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Monarch Research Associates

Norfolk, Virginia, United States

Site Status

Children's Hospital and Regional Medical Center

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-01-335

Identifier Type: -

Identifier Source: org_study_id