Conditions: Systemic Sclerosis Scleroderma
Keywords: Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Ulcer prostacyclin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 148
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose. arm 2: Matching placebo sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose.

Interventions: intervention 1: treprostinil diethanolamine intervention 2: placebo
Intervention descriptions: intervention 1: oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID) intervention 2: None

Protocol document: