Open-Label Study of Oral Treprostinil in Digital Ulcers - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received on February 16, 2009. Last Updated on January 13, 2011 History of Changes

Sponsor:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00848107

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:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Scleroderma

Drug Information available for: U 62840 Diethanolamine Remodulin

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 ]

Estimated Enrollment:	150
Study Start Date:	August 2009

Intervention Details:

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

More Information

No publications provided

Responsible Party:	Kristan Rollins, PharmD, United Therapeutics
ClinicalTrials.gov Identifier:	NCT00848107 History of Changes
Other Study ID Numbers:	TDE-DU-202
Study First Received:	February 16, 2009
Last Updated:	January 13, 2011
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 February 09, 2012