Open-Label Study of Oral Treprostinil in Digital Ulcers
NCT ID: NCT00848107
Last Updated: 2024-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
115 participants
INTERVENTIONAL
2009-09-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treprostinil
Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
treprostinil diethanolamine
sustained release tablet; BID dosing; up to 16 mg BID
Interventions
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treprostinil diethanolamine
sustained release tablet; BID dosing; up to 16 mg BID
Eligibility Criteria
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Inclusion Criteria
* If a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods \[such as a condom or diaphragm\] used with a spermicide, or an intrauterine device).
Exclusion Criteria
* Have been found to be unable to complete study assessments in the previous controlled trial;
* Have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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James Seibold, MD
Role: PRINCIPAL_INVESTIGATOR
Scleroderma Research Consultants LLC
Locations
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University of Alabama - Birmingham - Arthritis Clinical Intervention Program
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
UCLA
Los Angeles, California, United States
Barbara Davis Centre
Aurora, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Georgetown University - Dept. of Medicine/Rheumatology
Washington D.C., District of Columbia, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Johns Hopkins University - Division of Rheumatology
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Michigan - Scleroderma Program
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
UMDNJ Clinical Research Center
New Brunswick, New Jersey, United States
North Shore - LIJ Health System
Lake Success, New York, United States
The Hospital for Special Surgery
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Mason Medical
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
St Joseph's Health Care
London, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Royal Free Hospital - Center for Rheumatology
London, , United Kingdom
Salford Royal Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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TDE-DU-202
Identifier Type: -
Identifier Source: org_study_id
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