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| Sponsor: | United Therapeutics |
|---|---|
| Information provided by: | United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00775463 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Sclerosis Scleroderma |
Drug: treprostinil diethanolamine Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study |
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: treprostinil diethanolamine |
Drug: treprostinil diethanolamine
oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID)
|
| Placebo Comparator: placebo (sugar pill) | Drug: placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 32 Study Locations| Principal Investigator: | James Seibold, MD |
More Information
| Responsible Party: | Kristan Rollins, PharmD Sr Clinical Research Scientist, United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00775463 History of Changes |
| Other Study ID Numbers: | TDE-DU-201 |
| Study First Received: | October 17, 2008 |
| Last Updated: | January 13, 2011 |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Research Ethics Committee |
|
Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Ulcer prostacyclin |
|
Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Sclerosis Connective Tissue Diseases Skin Diseases |
Pathologic Processes Treprostinil Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |