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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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
|---|---|
| treprostinil diethanolamine: Experimental |
Drug: treprostinil diethanolamine
oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID)
|
| placebo (sugar pill): Placebo Comparator | 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| Contact: Kristan Rollins, PharmD | 919-425-8167 | krollins@unither.com |
Show 26 Study Locations| Principal Investigator: | James Seibold, MD | University of Michigan Scleroderma Program |
More Information
| Responsible Party: | United Therapeutics ( Kristan Rollins, PharmD Sr Clinical Research Scientist ) |
| Study ID Numbers: | TDE-DU-201 |
| Study First Received: | October 17, 2008 |
| Last Updated: | August 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00775463 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Research Ethics Committee |
|
Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Ulcer prostacyclin |
|
Pathologic Processes Skin Diseases Therapeutic Uses Treprostinil Connective Tissue Diseases Scleroderma, Diffuse |
Sclerosis Scleroderma, Systemic Cardiovascular Agents Antihypertensive Agents Scleroderma, Localized Pharmacologic Actions |