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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 is a Phase 4 study that has completed, run by The Medicines Company. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02452918
The ClinicalTrials.gov registry entry for NCT02452918 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Medicines Company, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT02452918 reports 0 study locations.
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.
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