Status:
COMPLETED
Juvista (Avotermin) in Scars Following Varicose Vein Removal
Lead Sponsor:
Renovo
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Varicose Veins
Cicatrix
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This trial is being undertaken to investigate the efficacy and safety of Juvista in the improvement of scar appearance when administered to approximated wound margins following varicose vein surgery. ...
Detailed Description
Patients undergoing bilateral removal of the saphenous vein (by ligation and stripping) will be invited to participate in the study. Consenting patients will undergo a detailed screening examination, ...
Eligibility Criteria
Inclusion
- Male and female patients between 18 and 85 years of age.
- Patients undergoing surgical removal of bilateral varicose veins by ligation and stripping, which will result in clinically similar (i.e. size and location) wounds at the groin and knee.
- Patients who have provided written informed consent.
- Patients with a body mass index between 15 and 35 kg/m2 inclusive.
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 6.4.1).
- Female patients of child bearing potential using method(s) of contraception acceptable to the Investigator and who agree to do so from at least the screening visit until one month after administration of the Investigational Medicinal Product.
Exclusion
- Patients who have had previous surgical treatment for varicose veins.
- Patients with a history of a bleeding disorder.
- Patients with a chronic or currently active skin disorder which may adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Patients who on direct questioning and/or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
- Patients who are taking or have taken investigational drugs in the 3 months prior to the screening visit.
- Patients with existing scars within 3cm of the potential trial wounds.
- Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy of the Investigational Product.
- Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- Patients who are taking regular, continuous, oral corticosteroid therapy.
- Patients undergoing investigations or changes in management for an existing medical condition.
- Patients who are pregnant or lactating.
- Patients who, in the opinion of the Investigator, are not likely to complete the trial.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00430326
Start Date
November 1 2006
End Date
April 1 2009
Last Update
March 9 2010
Active Locations (21)
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1
Ziekenhuis Oost Limburg
Genk, Belgium
2
Universitair Ziekenhuis Gent
Ghent, Belgium
3
P Stradinas Clinical University Hospital
Riga, Latvia
4
Kaunas 2nd Clinical Hospital
Kaunas, Lithuania