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Open-Label Study of Oral Treprostinil in Digital Ulcers (DISTOL-EXT)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00848107
First received: February 16, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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 this patient population


Condition Intervention
Systemic Sclerosis
 Drug: treprostinil diethanolamine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • adverse events and laboratory parameters [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • digital ulcers [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]
  • patient function and QOL [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: August 2009
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: treprostinil diethanolamine
    sustained release tablet; BID dosing; up to 16 mg BID
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible subjects who completed assessments for the final visit of the previous controlled trials and who signed appropriate informed consent are eligible to enroll in this extension study.
  • If a female of childbearing potential, the subject must agree 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848107

  Show 32 Study Locations
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: James Seibold, MD Scleroderma Research Consultants LLC
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00848107     History of Changes
Other Study ID Numbers: TDE-DU-202
Study First Received: February 16, 2009
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by United Therapeutics:
systemic sclerosis
scleroderma
digital ulcers
vasculopathy

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
 Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013