Study Stopped
The TDE-DU-202 extension study was discontinued after the randomized, placebo-controlled TDE-DU-201 study did not meet its primary efficacy objective.
Open-Label Study of Oral Treprostinil in Digital Ulcers
DISTOL-EXT
Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study
1 other identifier
interventional
115
3 countries
26
Brief Summary
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
February 7, 2014
CompletedJune 18, 2024
January 1, 2014
2 years
February 16, 2009
July 12, 2013
May 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment
Net ulcer burden at any given assessment was defined as the number of "new" or "active" ulcers at that assessment, plus the number of "indeterminate" ulcers at that assessment that had previously been classified as either "active" or "new" at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.
Baseline and Months 1, 3, 6, 9, 12, and 18
Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment
The total ulcer number includes all ulcers designated as "active", "indeterminate", or "new" for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.
Baseline and Months 1, 3, 6, 9, 12, and 18
Formation of New Ulcers
The number and percentage of subjects who developed new ulcers during the study were summarized.
18 months (or last study visit)
Secondary Outcomes (2)
Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment
Baseline and Months 1, 3, 6, and 12
Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment
Baseline and Months 1, 3, 6, and 12
Study Arms (1)
Treprostinil
EXPERIMENTALTreprostinil 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).
Interventions
Eligibility Criteria
You may qualify if:
- Eligible subjects who completed assessments for the final visit of the previous TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study.
- 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).
You may not qualify if:
- Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama - Birmingham - Arthritis Clinical Intervention Program
Birmingham, Alabama, 35294-7201, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
UCLA
Los Angeles, California, 90095-1670, United States
Barbara Davis Centre
Aurora, Colorado, 80045, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-1310, United States
Georgetown University - Dept. of Medicine/Rheumatology
Washington D.C., District of Columbia, 20007, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Johns Hopkins University - Division of Rheumatology
Baltimore, Maryland, 21224, United States
Boston University School of Medicine
Boston, Massachusetts, 02118-2526, United States
University of Michigan - Scleroderma Program
Ann Arbor, Michigan, 48106, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
UMDNJ Clinical Research Center
New Brunswick, New Jersey, 08903, United States
North Shore - LIJ Health System
Lake Success, New York, 11042, United States
The Hospital for Special Surgery
New York, New York, 10021, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Toledo
Toledo, Ohio, 43614, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-8900, United States
University of Texas - Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Mason Medical
Seattle, Washington, 98101, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
St Joseph's Health Care
London, Ontario, N6A 4V2, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Royal Free Hospital - Center for Rheumatology
London, NW3 2QG, United Kingdom
Salford Royal Hospital
Manchester, M13 9PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Interpretation of the change in digital ulcer status was limited by the lack of a control group and the discontinuation of the study prior to subjects completing all scheduled visits.
Results Point of Contact
- Title
- Rex Mauthe, Assoc VP, Regulatory Affairs
- Organization
- United Therapeutics Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
James Seibold, MD
Scleroderma Research Consultants LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2009
First Posted
February 20, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 18, 2024
Results First Posted
February 7, 2014
Record last verified: 2014-01