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

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Otsuka

Status and phase

Completed
Phase 4

Conditions

Raynaud's Disease

Treatments

Drug: Pletal

Study type

Interventional

Funder types

Industry

Identifiers

NCT00048763
21-01-335

Details and patient eligibility

About

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.

Sex

All

Ages

5 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion critera:

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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