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High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

NCT05342532 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-02-01

Study results available
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Summary

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Amoxicillin

1 g

DRUG

Omeprazole

40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.

DRUG

Clarithromycin

500 mg twice daily

Sponsors & Collaborators

Principal Investigators

  • Ilan Weisberg, MD, MSc · Mount Sinai Beth Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2022-01-01
Completion
2022-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05342532 on ClinicalTrials.gov