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NCT01475786 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy
A Phase 2 study, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT01475786: Completed Phase 2 study, sponsored by Helixmith Co..
NCT01475786 is a Phase 2 study that has completed, run by Helixmith Co.. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475786, a Phase 2 study, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.
Primary Outcome
The difference in the mean change of the 24 hour pain score was compared between the treatment groups and the placebo arm to determine treatment effect. The average pain scores were obtained from the Daily Pain and Sleep Interference Diary (recorded daily by subjects for 7 days during Screening prior to the first round of injections and again, before the 6 month follow-up). Subjects rated their 24-hor daily pain intensity according to the 11-point numerical rating scale from 0 (no pain) to 10 (w
Interventions
- BIOLOGICAL Low Dose: 16 mg Engensis (VM202)
- BIOLOGICAL High Dose: 32 mg Engensis (VM202)
- OTHER Control- Placebo (normal saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT01475786 record still lists
NCT01475786 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Low Dose: 16 mg Engensis (VM202) is the first listed.
NCT01475786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01475786 about?
NCT01475786 is a clinical study titled "Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy". The purpose of this study is to determine if Engensis (VM202) is safe and effective in treating painful diabetic neuropathy.
What is the current status of trial NCT01475786?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2012-08. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01475786?
The interventions under investigation include: Low Dose: 16 mg Engensis (VM202) (BIOLOGICAL), High Dose: 32 mg Engensis (VM202) (BIOLOGICAL), Control- Placebo (normal saline) (OTHER).
Who is sponsoring clinical trial NCT01475786?
This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01475786's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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