Study:
DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study
Rationale:
n/a
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Systemic Sclerosis
Scleroderma |
Drug: treprostinil diethanolamine
Drug: placebo |
Phase 2 |
Verified by
United Therapeutics
January, 2011
Sponsored by: United Therapeutics
Information provided by: United Therapeutics
ClinicalTrials.gov identifier: NCT00775463
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cleveland Clinic Foundation/Dept. of Rheumatologic and Immunologic Disease
Cleveland, Ohio 44195
United States
James Seibold, MD., Principal Investigator