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Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

NCT00775463 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-12-28

Study results available
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Summary

This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic wounds.

Conditions

Interventions

DRUG

treprostinil diethanolamine

oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID)

DRUG

placebo

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Seibold, MD · Scleroderma Research Consultants LLC, Avon, CT,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-03-31
Completion
2011-07-31

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775463 on ClinicalTrials.gov