E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
Evaluate the effect of the IMP on the itch, associated with atopic dermatitis |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the effect of the IMP on the atopic dermatitis lesions |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Caucasian, male or female of NO childbearing potential (at least 2 years post-menopausal or undergone successful surgical sterilization at least 1 year before inclusion), aged between 18 and 60 (extremes included)
2. Confirmed diagnosis of atopic dermatitis according to the criteria of Hanifin & Rajka, with active disease and a itch score of at least moderate
3. Subjects willing and eligible to apply 1% hydrocortisone acetate cream and emollient
4. Ability to use visual analog scale |
|
E.4 | Principal exclusion criteria |
1. History of drug allergy to antihistamines, other anti-allergic compounds, quinine or any of the components of the study medication
2. History or suspicion of alcohol and/or drug abuse
3. Subjects having following concomitant disorders: significant hepatic, renal or bone marrow diseases, severe neuropathy including multiple sclerosis, significant psychiatric disorders or any other serious disease (including cancer and subjects known to be HIV positive), significant infection that requires systemic antibiotic treatment
4. Any disease state or physical condition that, in the investigator’s opinion, may impair evaluation of itch and/or the atopic dermatitis lesions, or may interfere with the treatment 5. Out-of-range laboratory test results that the investigator considers as pathologic 6. History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders.
7. Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males.
8. Pregnant or breastfeeding women, or women of childbearing potential |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the change from baseline in itch score at visit 3, as scored by the investigator. |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | 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 | Yes |
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.8.5 | 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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |