Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by OcuNexus Therapeutics. The registered enrollment target is 98 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00820196
The ClinicalTrials.gov registry entry for NCT00820196 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OcuNexus Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nexagon® vehicle is the first listed.
NCT00820196 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.