Raynaud's DiseasePhase 4NCT00048763
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
A Phase 4 study testing Pletal in people with Raynaud's Disease, run by Otsuka America Pharmaceutical at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Raynaud's Disease
- What is being tested?
- Pletal
- How many people
- 75 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2001to Jun 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5 to 6 years old
- fulfill diagnostic criteria for primary or secondary Raynaud's
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Advanced Medical Clinical Therapeutics
Anchorage, Alaska, 99508
Children's Hospital Boston
Boston, Massachusetts, 02115
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Children's Hospital of Buffalo
Buffalo, New York, 14222
Medical University of South Carolina
Charleston, South Carolina, 29425
LaRabida Children's Hospital
Chicago, Illinois, 60649
Advanced Medical Research Institute
Fresno, California, 93710
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Madera Family Medical Group
Madera, California, 93637
Schneider Children's Hospital
New Hyde Park, New York, 11040
Asthma & Allergy Research Center
Newark, New Jersey, 07103
Monarch Research Associates
Norfolk, Virginia, 23510
Children's Hospital
Omaha, Nebraska, 68114
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
St. Louis University Health Sciences Center
St Louis, Missouri, 63104
Jobst Vascular Center
Toledo, Ohio, 43606
New York Medical College
Valhalla, New York, 10595
About this study
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.
- Conditions
- Raynaud's Disease
- Being tested
- Pletal
- Keywords
- circulatory, vascular, idiopathic
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PletalDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2002 (estimated)
- Study startOct 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Otsuka America Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048763
- Sponsor's protocol ID
- 21-01-335
- Status last verified
- Jul 2005
- First submitted
- 7 Nov 2002
- Last updated
- 19 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT00048763
- Acronym / sponsor ID
- 21-01-335
- Conditions
- Raynaud's Disease
- Keywords
- circulatory, vascular, idiopathic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Otsuka America PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Jun 2003
- First posted
- 11 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 5 to 6 years old
- fulfill diagnostic criteria for primary or secondary Raynaud's
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pletal | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2005.
Related trials for Raynaud's Disease
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Not yet recruitingPhase 2
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Not yet recruitingPhase 3
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Buerger Disease, Raynaud Syndrome
RecruitingPhase 4
Open Label Treprostinil Raynaud's Study
Raynaud's Disease, Raynaud Phenomena
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pletal in people with Raynaud's Disease, run by Otsuka America Pharmaceutical at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2005.