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NCT02045797 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT02045797: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02045797 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02045797, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study designed to select the optimal dose by further characterizing the safety, tolerability and PK of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure infections (ABSSSI). The selected dose will be used in future studies.
Primary Outcome
Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=\>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.
Interventions
- DRUG GSK2140944 Lyophile
- DRUG GSK2140944 Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-03-24 |
| Est. Completion | 2015-06-29 |
| Phase | Phase 2 |
What the finished NCT02045797 record still lists
NCT02045797 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which GSK2140944 Lyophile is the first listed.
NCT02045797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02045797 about?
NCT02045797 is a clinical study titled "Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections". GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study designed to select the optimal dose by further characterizing the safety, tolerability and PK of GSK 2140944 and by evaluating...
What is the current status of trial NCT02045797?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2014-03-24. Estimated completion is 2015-06-29.
What interventions are being tested in trial NCT02045797?
The interventions under investigation include: GSK2140944 Lyophile (DRUG), GSK2140944 Capsules (DRUG).
Who is sponsoring clinical trial NCT02045797?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02045797's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 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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