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NCT00848107 · ClinicalTrials.gov registry record · Phase 2
Open-Label Study of Oral Treprostinil in Digital Ulcers
A Phase 2 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT00848107: Clinical Trial Phase 2 study, sponsored by United Therapeutics.
NCT00848107 is a Phase 2 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 115 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00848107, a Phase 2 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.
Primary Outcome
Net ulcer burden at any given assessment was defined as the number of "new" or "active" ulcers at that assessment, plus the number of "indeterminate" ulcers at that assessment that had previously been classified as either "active" or "new" at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.
Interventions
- DRUG treprostinil diethanolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT00848107 stopped before completion
NCT00848107 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 1 intervention - of which treprostinil diethanolamine is the first listed.
NCT00848107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00848107 about?
NCT00848107 is a clinical study titled "Open-Label Study of Oral Treprostinil in Digital Ulcers". This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.
What is the current status of trial NCT00848107?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2009-09. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00848107?
The interventions under investigation include: treprostinil diethanolamine (DRUG).
Who is sponsoring clinical trial NCT00848107?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00848107's enrollment target sits among peer trials
115 626th of 2000 higher than 1,374 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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