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Juvista (Avotermin) in Scars Following Varicose Vein Removal

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ClinicalTrials.gov Identifier: NCT00430326
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : March 9, 2010
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by:
Renovo

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 1, 2007
Last Update Posted Date March 9, 2010
Study Start Date  ICMJE November 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
  • Investigator scar assessment [ Time Frame: 7 & 12 months ]
  • Patient scar assessment [ Time Frame: up to 12 months ]
  • Independent scar assessment [ Time Frame: 7 & 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Investigator scar assessment
  • Patient scar assessment
  • Independent scar assessment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
  • Local tolerance [ Time Frame: ongoing to 12 months ]
  • Adverse events [ Time Frame: ongoing to12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
  • Local tolerance
  • Adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Juvista (Avotermin) in Scars Following Varicose Vein Removal
Official Title  ICMJE A Dose Response Trial to Investigate the Efficacy of Juvista (Avotermin) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins Following Bilateral Varicose Vein Removal.
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. The results from this trial will be used to select doses for investigation in future clinical trials with the compound.
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, after which suitability to progress to randomisation to the study will be confirmed.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Varicose Veins
  • Cicatrix
Intervention  ICMJE Drug: Avotermin
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 31, 2007)		 156
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Latvia,   Lithuania,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430326
Other Study ID Numbers  ICMJE RN1001-0042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Julia Day, Clinical Trial Manager, Renovo
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Renovo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
Principal Investigator: Peter McCollum, MB MCh FRCS Hull Royal Infirmary
PRS Account Renovo
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP