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Sponsored by: |
CoDa Therapeutics Inc. |
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Information provided by: | CoDa Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT00820196 |
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.
Condition | Intervention | Phase |
---|---|---|
Venous Ulcer |
Drug: Nexagon® Drug: Nexagon® vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose-Ranging, Multi-Center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers |
Estimated Enrollment: | 90 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who are currently taking:
Patients with:
Patients with:
Contact: Andrew Jull, PhD | (09) 373 7599 ext 84744 | a.jull@ctru.auckland.ac.nz |
Contact: Elizabeth Glen | (09) 373 7599 ext 84662 | e.glen@ctru.auckland.ac.nz |
Principal Investigator: | Andrew Jull, PhD | Clinical Trials Research Organization |
Responsible Party: | CoDa Therapeutics ( Scott Bannan ) |
Study ID Numbers: | NEX-ULC-001 |
Study First Received: | January 8, 2009 |
Last Updated: | January 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00820196 |
Health Authority: | New Zealand: Medsafe |
Venous ulcer Nexagon CoDa |
Varicose Ulcer Skin Diseases Varicose Veins Ulcer |
Vascular Diseases Skin Ulcer Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |