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NCT02452918 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
A Phase 4 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT02452918: Completed Phase 4 study, sponsored by The Medicines Company.
NCT02452918 is a Phase 4 study that has completed, run by The Medicines Company. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02452918, a Phase 4 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalizati
Interventions
- DRUG Warfarin
- DRUG Oritavancin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-09-29 |
| Est. Completion | 2016-07-05 |
| Phase | Phase 4 |
What the finished NCT02452918 record still lists
NCT02452918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT02452918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02452918 about?
NCT02452918 is a clinical study titled "A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)". This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional g...
What is the current status of trial NCT02452918?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2015-09-29. Estimated completion is 2016-07-05.
What interventions are being tested in trial NCT02452918?
The interventions under investigation include: Warfarin (DRUG), Oritavancin (DRUG).
Who is sponsoring clinical trial NCT02452918?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02452918's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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