Juvista (Avotermin) in Scars Following Varicose Vein Removal
NCT ID: NCT00430326
Last Updated: 2010-03-09
Study Results
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Basic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2006-11-30
2009-04-30
Brief Summary
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Detailed Description
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Suitable screened patients will attend for scheduled surgery of vein removal as normal - this is termed "Day 0" At the time of wound closure, IMP will be administered via intra-dermal injection to each of the incisional groin wounds, and exit wounds.
Each patient will serve as their own control with one leg being administered active IMP (at either a 5, 50, 200 or 500ng/100 ul)of dose solution, whilst the other leg is administered placebo solution. The study is double-blinded, so neither the Investigator nor patient will know which leg wounds receive which treatment.
Further to Day 0, the patients are requested to attend for a further 5 follow up visits (Week 6, Month 3, Month 5, Month 7 \& Month 12), where photographs of the scars will be taken, together with spectrophotometry readings to measure colour of the scar. At each visit, the Investigator and patient will rate their opinion of the scar, by global assessment scale \& VAS, together with patient completed questionnaires.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Interventions
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Avotermin
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
Renovo
INDUSTRY
Responsible Party
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Renovo
Principal Investigators
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Peter McCollum, MB MCh FRCS
Role: PRINCIPAL_INVESTIGATOR
Hull Royal Infirmary
Locations
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Ziekenhuis Oost Limburg
Genk, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
P Stradinas Clinical University Hospital
Riga, , Latvia
Kaunas 2nd Clinical Hospital
Kaunas, , Lithuania
Klaipeda Seaman Hospital
Klaipėda, , Lithuania
Vilnius City University Hospital
Vilnius, , Lithuania
Belfast City Hospital
Belfast, , United Kingdom
Heartlands Hospital
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Derby City General Hospital
Derby, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Gloucester Royal Hospital
Gloucester, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
St Georges Hospital
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
Countries
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References
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McCollum PT, Bush JA, James G, Mason T, O'Kane S, McCollum C, Krievins D, Shiralkar S, Ferguson MW. Randomized phase II clinical trial of avotermin versus placebo for scar improvement. Br J Surg. 2011 Jul;98(7):925-34. doi: 10.1002/bjs.7438. Epub 2011 Mar 29.
Other Identifiers
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RN1001-0042
Identifier Type: -
Identifier Source: org_study_id
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