ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator

Inclusion Criteria

• Be ages 18 - 70, inclusive; non-Asian males and females (This population has been demonstrated to have significantly elevated omeprazole levels as per the prescriber information for other omeprazole products). A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam should be considered Asian, and forr this study Asian is defined as having at least one Asian grandparent (Shektar et al, 2014, FDA Guidance for Industry 2016);
• Positive for H. pylori by 13C Urea Breath Test (UBT) and confirmed positive via gastric biopsy for campylobacter-like organism (CLO) Rapid Urease Test, or H. pylori culture or histology;
• Symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals);
• Females must not be pregnant or lactating and:
• at no risk of pregnancy for one of the following reasons: postmenopausal for at least one year from the date of informed consent, status post hysterectomy or tubal ligation, OR
• are prepared to and agree to use of an intrauterine device (IUD) or practice double method birth control (barrier plus spermicide) from screening through to 30 days post-end of-treatment (EOT); Acceptable double contraceptive methods include barrier (condoms or diaphragms) plus spermicide
• Hormonal contraceptives (birth control pills and hormone implants) are not acceptable contraception methods under this protocol;
• Males must be surgically sterilized or are prepared to and agree to practice double method (barrier plus spermicide) birth control from screening through to 30 days post-EOT;
• Agree to refrain from consuming alcohol from 1 week prior to screening to Test of Cure/Visit 5;
• Agree to refrain from taking antacids from screening through day 15 and for at least 24 hours prior to Test of Cure/Visit 5 and if applicable at least 24 hours prior to Visit 8/Test of Cure;
• Agree to refrain from taking H2 blockers at least 24 hours prior to screening 13C UBT and at least 24 hours prior to Test of Cure/Visit 5 and if applicable at least 24 hours prior to Visit 8/Test of Cure;
• Agree to refrain from taking sucralfate from one week prior to screening through Test of Cure/Visit5;
• Agree to refrain from taking bismuth containing medications such as Pepto-BismolTM or other proton pump inhibitors (PPIs) from two weeks prior to screening through Test of Cure/Visit 5;
• Agrees to refrain from consuming grapefruit, or any other food or supplement known to significantly affect CYP3A4 or CYP2C19 activity from screening to day 15;
• Provide written informed consent to participate as shown by a signature of subject on the consent form.

Exclusion Criteria

• Have alarm symptoms/signs (including unexplained anemia [iron deficiency], melena / hematemesis, anorexia, dysphagia, jaundice, weight loss);
• Have received prior H. pylori eradication therapy;
• Use of antibiotics in the 4 weeks immediately prior to screening 13C UBT;
• Use of any proton pump inhibitors (PPIs) or bismuth-containing medications (such as Pepto-BismolTM) within the 2 weeks immediately prior to screening 13C UBT;
• Use of any of the following medications within seven days prior screening: alfentanil, allopurinol, amlodipine, anti-herpes agents, anti-retroviral agents, apixaban, aprepitant, aripiprazole, astemizole, atorvastatin, boceprevir, buspirone, carbamazepine, cisapride, citalopram dosed greater than 20 mg /d, clomipramine, clopidogrel and other oral anticoagulants, colchicine, dapsone, dihydroergotamine, digoxin, diltiazem, ergotamine, felodipine, fluconazole, gleevec, hormonal contraceptives that are not exclusively norethindrone or norgestrel, imipramine, itraconazole, ketoconazole, latuda, lovastatin, mycophenolate mofetil, n