E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing varicose vein removal with ligation and stripping.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the dose response efficacy of Juvista in the improvement of scar appearance when applied to the approximated wound margins of patients undergoing surgical removal of varicose veins. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety of Juvista when applied to the approximated wound margins of patients following varicose vein surgery.
To examine the systemic absorption of Juvista when given intradermally to patients undergoing bilateral varicose vein surgery. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 with exit wounds at either the knee or the ankle. Patients who have provided written informed consent. Patients with a body mass index between 15 and 35kg/m2 inclusive. Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. 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 last dose of IMP. |
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E.4 | Principal exclusion criteria |
Patients who have had previous surgical treatment for varicose veins. Paients 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 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 the 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
This will be the Total Scar Score (ToScar) of the groin wound from the Independent External Scar Assessment Panel VAS scores at each trial time point up to Month 7. Success will be defined as a statistically significant difference in ToScar between the active and placebo treatments. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The primary efficacy analysis for this trial will be based on data collected up to and including the Month 7 visit. An additional follow-up visit will be performed at Month 12.
The end of trial will thus be notified to Competent Authority and Ethics Committees following the last assessment from the Month 12 visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |