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

NCT ID: NCT05342532

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2022-01-01

Brief 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.

Detailed Description

All patients, at least 18 years of age, with a chief complaint of dyspepsia and documented treatment-naïve HP infection diagnosed on UBT, esophagogastroduodenoscopy (EGD) with HP biopsy, or SAT were recruited for the study. Dyspepsia was defined as persistent or recurrent abdominal pain for at least one month. All subjects who met inclusion criteria were randomly assigned by a computerized system to one of two treatment groups: standard triple therapy (STT) or high-dose dual therapy (HDDT). After patient randomization, all potential side effects were discussed. Education regarding the importance of adherence to complete the full 14 day regimen was provided. Patients were provided an electronic prescription for the respective assigned regimen along with a medication log to self-report drug compliance. The patients were asked to record medication compliance and report any adverse events to research personnel.

After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. During this period, patients were asked to abstain from taking PPI's to avoid false negative eradication testing. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Dose Dual Therapy

This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

1 g

Omeprazole

Intervention Type: DRUG

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

Standard triple therapy

This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

1 g

Omeprazole

Intervention Type: DRUG

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

Clarithromycin

Intervention Type: DRUG

500 mg twice daily

Interventions

Amoxicillin

1 g

Intervention Type: DRUG

Omeprazole

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

Intervention Type: DRUG

Clarithromycin

500 mg twice daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ilan S Weisberg

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilan Weisberg, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Beth Israel

Locations

Mount Sinai Union Square Division of Digestive Diseases

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STUDY-19-01590

Identifier Type: -

Identifier Source: org_study_id