E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcers in which the presence of meticillin resistant Staphylococcus aureus (MRSA) has been identified. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045285 |
E.1.2 | Term | Ulcer |
|
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 determine the efficacy of topically applied gaseous nitric oxide to reduce microorganisms including MRSA. |
|
E.2.2 | Secondary objectives of the trial |
To determine the effect of the application of gaseous nitric oxide on the condition of the ulcer.
To determine the safety of the treatment as measured by the incidence of adverse events. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject: - Must have given written informed consent - Must be 18 years of age or over and, if female, not of child bearing potential - Must have an ulcer in which the presence of MRSA has been positively identified but which is not clinically infected. - Must have an ulcer size not to extend beyond the inner borders of the dressing. |
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E.4 | Principal exclusion criteria |
Subject: -Is pregnant or a female who could become pregnant - Is < 18 years of age - Has a clinically infected ulcer - Has an ulcer that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment. - Is using systemic antibiotics or has been using systemic antibiotics during 7 days prior to enrolment into this study. - Has an ulcer which is identified as malignant in origin (e.g., Marjolin’s ulcer) - Has an ulcer size beyond the inner borders of the dressing - Is septic or has other signs of an invasive infection - Has used any investigational product within 30 days preceding study participation. - Suffers from a condition, which, in the opinion of the Investigator, would compromise his or her safety. - Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data. - Has a known allergy to any of the products that are part of this protocol - Is immune deficient - Is using any of the prohibited concomitant medications or treatments |
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E.5 End points |
E.5.1 | Primary end point(s) |
A 3-Log (or better) reduction in microorganisms including MRSA. |
|
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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |