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Clinical trial

High-Dose Dual Therapy vs Standard Triple Therapy for Treatment-Naïve H. Pylori: A Prospective Randomized Control Trial in a Diverse Urban New York City Population

ID
Name
STUDY-19-01590
Description
A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban New York City population.
Trial arms
Trial start
2019-06-12
Estimated PCD
2022-01-01
Trial end
2022-01-01
Status
Completed
Phase
Early phase I
Treatment
Amoxicillin
1 g
Arms:
High Dose Dual Therapy, Standard triple therapy
Omeprazole
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Arms:
High Dose Dual Therapy, Standard triple therapy
Clarithromycin
500 mg twice daily
Arms:
Standard triple therapy
Size
112
Primary endpoint
Number of Participant With Eradication of Disease
end of study at 6 weeks
Eligibility criteria
Inclusion Criteria: * Age 18 or older * Treatment-naïve * Clinical diagnosis of helicobacter pylori infection based on urea breath test, endoscopy or stool antigen test * Subject willing to participate and able to provide informed consent. Exclusion Criteria: * Prior helicobacter pylori treatment failure * Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis * Pregnancy or breastfeeding * Penicillin allergy * History of active or non-gastric malignancy * Severe illness requiring hospitalization during treatment period * Starting additional antibiotic while on treatment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 112, 'type': 'ACTUAL'}}
Updated at
2023-02-01

1 organization

3 products

1 indication

Organization
Icahn School of Medicine at Mount Sinai
Product
Amoxicillin
Indication
Helicobacter pylori infection
Product
Omeprazole
Product
Clarithromycin