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NCT03664921 · ClinicalTrials.gov registry record · Phase 2
Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
A Phase 2 study, sponsored by Syntrix Biosystems.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT03664921: Completed Phase 2 study, sponsored by Syntrix Biosystems.
NCT03664921 is a Phase 2 study that has completed, run by Syntrix Biosystems. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664921, a Phase 2 study, has completed, sponsored by Syntrix Biosystems.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.
Primary Outcome
Subjects rate their pain intensity on a scale from 0 = no pain to 10 = worst possible pain
Interventions
- DRUG Placebo Oral Tablet
- DRUG Omnitram Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2020-08-17 |
| Phase | Phase 2 |
What the finished NCT03664921 record still lists
NCT03664921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03664921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03664921 about?
NCT03664921 is a clinical study titled "Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy". This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.
What is the current status of trial NCT03664921?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2018-11-15. Estimated completion is 2020-08-17.
What interventions are being tested in trial NCT03664921?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Omnitram Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03664921?
This trial is sponsored by Syntrix Biosystems, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03664921's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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