NCT00775463

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Systemic Sclerosis
• Scleroderma

Interventions

Type	Name	Description
DRUG	treprostinil diethanolamine	oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID)
DRUG	placebo

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2008-10-20
• Last updated: 2023-12-28
• Results posted: 2014-03-17

Locations

30 sites across 3 countries: United States, Canada, United Kingdom