Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT07224035
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years of age
Exclusion Criteria:
* Adults with a personal history of gastric cancer
* Adults with prior history of H. Pylori (HP) treatment and confirmed eradication
* Adults unable to consent
* Adults unable to consent in their preferred language
* Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed
* Prisoners
* Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®:
* vonoprazan
* amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins)
* clarithromycin or any other macrolide antimicrobial (e.g. erythromycin)
* Persons presently taking any of the following:
* Rilpivirine-containing products
* Pimozide
* Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin
* Ergot alkaloids
* Colchicine (if with kidney or liver impairment)
* Lurasidone
* Drugs known to prolong the QT interval (e.g., pimozide).
* Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Verapamil, amlodipine, diltiazem, nifedipine
* Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin
* Quetiapine
* Warfarin
* Benzodiazepines (e.g. triazolam, midazolam)
* Persons who have any of the following, as they may be prone to adverse effects from the medication regimen:
* History of cholestatic jaundice
* Severe kidney impairment
* Severe hepatic impairment
* Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes.
* Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
* Participants with ongoing mononucleosis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07224035
Study Brief:
Protocol Section:
NCT07224035