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NCT04962139 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
A Phase 3 study, sponsored by Oneness Biotech Co..
- Terminated
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT04962139: Clinical Trial Phase 3 study, sponsored by Oneness Biotech Co..
NCT04962139 is a Phase 3 study that was terminated before completion, run by Oneness Biotech Co.. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04962139, a Phase 3 study, was terminated before completion, sponsored by Oneness Biotech Co..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
Primary Outcome
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by blinded independent evaluators.
Interventions
- OTHER Vehicle Cream
- DRUG ON101 Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2022-11-29 |
| Phase | Phase 3 |
Why NCT04962139 stopped before completion
NCT04962139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Cream is the first listed.
NCT04962139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04962139 about?
NCT04962139 is a clinical study titled "Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers". The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
What is the current status of trial NCT04962139?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2021-07-27. Estimated completion is 2022-11-29.
What interventions are being tested in trial NCT04962139?
The interventions under investigation include: Vehicle Cream (OTHER), ON101 Cream (DRUG).
Who is sponsoring clinical trial NCT04962139?
This trial is sponsored by Oneness Biotech Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04962139's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 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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