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NCT02925416 · ClinicalTrials.gov registry record · Phase 4
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
A Phase 4 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT02925416: Completed Phase 4 study, sponsored by The Medicines Company.
NCT02925416 is a Phase 4 study that has completed, run by The Medicines Company. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02925416, a Phase 4 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.
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. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in any
Interventions
- DRUG Oritavancin
- DRUG Placebo (D5W)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-01-24 |
| Est. Completion | 2017-06-20 |
| Phase | Phase 4 |
What the finished NCT02925416 record still lists
NCT02925416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Oritavancin is the first listed.
NCT02925416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02925416 about?
NCT02925416 is a clinical study titled "Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection". The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.
What is the current status of trial NCT02925416?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2017-01-24. Estimated completion is 2017-06-20.
What interventions are being tested in trial NCT02925416?
The interventions under investigation include: Oritavancin (DRUG), Placebo (D5W) (DRUG).
Who is sponsoring clinical trial NCT02925416?
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 NCT02925416's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 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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