E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031744 |
E.1.2 | Term | Other chronic otitis externa |
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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 establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment. |
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E.2.2 | Secondary objectives of the trial |
1. to establish effect of tacrolimus ointment on the skin and microbiological flora of the external auditory canal. This will be evaluated by treatment group comparisons of the microbiological swabs at visit 1 (baseline) and visit 3 (day 14)
2. to define treatment guidelines of chronic eczematous otitis externa using tacrolimus ointment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patient, aged 18 or older, regardless of race. 2. Patient has been diagnosed with bilateral chronic eczematous otitis externa and has received standard treatment at the ENT clinic for 6 months without having achieved satisfactory clinical control of the condition. 3. Women of child bearing potential must use an acceptable method of birth control prior and have a negative urine pregnancy test prior to study entry. 4. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. 5. Subjects should not receive vaccinations during the study or 14 days before or after the study. In case of live attenuated vaccination, this period should be extended to 28 days before or after the study.
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E.4 | Principal exclusion criteria |
1. Patient is less than 18 years of age. 2. Patient is allergic or intolerant to macrolide antibiotics, tacrolimus, and/or its excipients. 3. Patient with malignancy or history of malignancy except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. 4. Subjects currently receiving immunosuppressive drugs. 5. Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 28 days before entry into this study. 6. Patient has been previously enrolled in this study. 7. Patient is unlikely to comply with the visits scheduled in the protocol. 8. Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator 9. Patient is pregnant or a breast-feeding mother.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. treatment group comparisons of the patient diary cards and the ENT Specialist’s evaluation and overall assessment
2. treatment group comparisons of the microbiological swabs at visit 1 (baseline) and visit 3 (day 14)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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 | Yes |
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) | Yes |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |