E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
walnut allergic patients |
Pacientes con alergia a la nuez |
|
E.1.1.1 | Medical condition in easily understood language |
walnut allergic patients |
Pacientes con alergia a la nuez |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016946 |
E.1.2 | Term | Food allergy |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
|
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 |
Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients |
Investigar el efecto del omeprazol en la curva de distribución de la dosis umbral y en la gravedad de los síntomas en pacientes con alergia a nuez. |
|
E.2.2 | Secondary objectives of the trial |
Determination of minimal eliciting dose of walnut protein in walnut allergic patients
Calculation of the dose of walnut protein leading to an allergic reaction in 5% (ED05) and 10% (ED10) of walnut allergic population
Analyse differences in walnut threshold distributions curves and severity related to allergen sensitisation pattern and geographical location |
Determinar la mínima dosis umbral en pacientes alérgicos a nuez.
Calcular la dosis de proteína de nuez que provocará una reacción alérgica en el 5% (ED05) y en el 10% (ED10) de la población alérgica a nuez.
Analizar las diferencias en la curva de distribución de dosis umbrales y en la gravedad de la alergia a nuez según el patrón de sensibilización a alérgenos y la localización geográfica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- positive case history of allergic reaction(s) to walnut
- age ? 18 years
- cutaneous reaction positive to walnut |
- Historia de reacción alérgica inmediata a nuez
- Edad ? 18 años
- Pruebas cutáneas a nuez positivas (diámetro de pápula? 3 mm) y/o IgE específica a nuez positiva ((? 0,35 KU/L mediante ImmunoCAP). |
|
E.4 | Principal exclusion criteria |
- intake of drugs interfering with Omeprazole or the allergic response under food challenge
- pregnancy, breastfeeding
- acute allergic disease
- epinefrine contraindication |
- Administración de fármacos que interfieran con omeprazol o con la respuesta alérgica en la provocación oral con la nuez.
- Embarazo, lactancia.
- Enfermedad alérgica aguda.
- Cualquier contraindicación para la administración de adrenalina o para la provocación oral con alimentos |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole
Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole |
Cambios en la dosis umbral de nuez que es capaz de inducir una reacción alérgica tras la administración de dosis terapéuticas de omeprazol.
Cambios en la gravedad de las reacciones alérgicas con nuez tras la administración de dosis terapéuticas de omeprazol |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
5th treatment day |
al quinto día de tratamiento con cada sustancia |
|
E.5.2 | Secondary end point(s) |
Determination of threshold dose-distribution curve in walnut allergy and calculation of the dose of walnut protein leading to allergic reactions in patients with confirmed food allergy to walnuts |
Determinación de la curva de distribución de dosis umbrales de nuez y cálculo de la dosis de proteína de nuez que produce reacciones alérgicas en pacientes con alérgicos a la misma. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
5th treatment day |
al quinto día de tratamiento con cada sustancia |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | No |
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 | 8 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |