iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions

Exclusion Criteria

• •• Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal
• •* Drugs not allowed during the study due to proved interaction with Omeprazole: Digoxin, Clopidogrel, Methotrexate, Antiretroviral drugs, Diazepam, Cilostazol, Phenytoin, Warfarin (R-Warfarin) and other Vitamin K antagonists, Phenytoin, Tacrolimus, Clarithromycin, voriconazole, Rifampicin and Hypericum
• •* Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge)
• •corticosteroids systemically (2 weeks)
• •antihistamines (3 days) except hydroxyzine (10 days)
• •ketotifen (2 weeks)
• •betablocker (1 day)
• •angiotensin converting enzyme (ACE) inhibitors (2 days)
• •omalizumab (2 months)
• •* Women who are pregnant or breast feeding
• •* Intention to become pregnant during the course of the study
• •* Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices
• •* Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• •* Uncontrolled asthma, forced expiratory volume \<70% predicted value
• •* Acute allergic disease
• •* Chronic urticaria
• •* Mastocytosis
• •* Other clinically significant concomitant disease states (major organic or infectious diseases, e.g., renal failure, hepatic dysfunction, cardiovascular disease, acute febrile infection),
• •* Known or suspected non-compliance, drug or alcohol abuse,
• •* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• •* Participation in another study with investigational drug within the 30 days preceding and during the present study