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NCT00820196 · ClinicalTrials.gov registry record · Phase 2
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
A Phase 2 study, sponsored by OcuNexus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT00820196: Completed Phase 2 study, sponsored by OcuNexus Therapeutics.
NCT00820196 is a Phase 2 study that has completed, run by OcuNexus Therapeutics. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00820196, a Phase 2 study, has completed, sponsored by OcuNexus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
Interventions
- DRUG Nexagon® vehicle
- DRUG Nexagon®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT00820196 record still lists
NCT00820196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Nexagon® vehicle is the first listed.
NCT00820196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00820196 about?
NCT00820196 is a clinical study titled "A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)". Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies wit...
What is the current status of trial NCT00820196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2009-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00820196?
The interventions under investigation include: Nexagon® vehicle (DRUG), Nexagon® (DRUG).
Who is sponsoring clinical trial NCT00820196?
This trial is sponsored by OcuNexus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00820196's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 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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