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NCT02127970 · ClinicalTrials.gov registry record · Phase 3
Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 698
- Enrollment target
NCT02127970: Completed Phase 3 study, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
NCT02127970 is a Phase 3 study that has completed, run by Durata Therapeutics Inc., an affiliate of Allergan. The registered enrollment target is 698 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127970, a Phase 3 study, has completed, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 698 participants
- Enrollment target
Study Summary
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.
Primary Outcome
Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpe
Interventions
- DRUG Dalbavancin
- DRUG Dalbavancin-matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2014-04-18 |
| Est. Completion | 2015-03-11 |
| Phase | Phase 3 |
What the finished NCT02127970 record still lists
NCT02127970 is an interventional study that assigns participants to a tested intervention. The registered 698 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Dalbavancin is the first listed.
NCT02127970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02127970 about?
NCT02127970 is a clinical study titled "Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections". To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -7...
What is the current status of trial NCT02127970?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 698 participants. The study started on 2014-04-18. Estimated completion is 2015-03-11.
What interventions are being tested in trial NCT02127970?
The interventions under investigation include: Dalbavancin (DRUG), Dalbavancin-matching Placebo (DRUG).
Who is sponsoring clinical trial NCT02127970?
This trial is sponsored by Durata Therapeutics Inc., an affiliate of Allergan, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02127970's enrollment target sits among peer trials
698 516th of 2000 higher than 1,483 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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