| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00775463 | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine | PHASE2 | COMPLETED | 148 | — | — | May 1, 2009 | Jul 1, 2011 | Dec 28, 2023 | 30 | United States, Canada +1 |
| NCT00848939 | Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis | PHASE1 | COMPLETED | 28 | — | — | Dec 1, 2008 | Apr 1, 2010 | Oct 23, 2012 | 3 | United States |
Net ulcer burden was defined as the number of "new" or "active" digital ulcers (DU), plus the number of "indeterminate" DUs at that assessment that have previously been classified as either "active" or "new" at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced "active." If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as "active." Otherwise, the DU was pronounced "indeterminate." Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed.
| Arm | Type | Description |
|---|---|---|
| treprostinil diethanolamine | EXPERIMENTAL | 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. |
| placebo (sugar pill) | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| treprostinil diethanolamine | DRUG | oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID) |
| placebo | DRUG | - |
Inclusion Criteria: * Subject gave voluntary written informed consent to participate in the study * Diagnosis of systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR) criteria * Males and females age greater than 18 years at Screening * Presence of at least one active digita...