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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT05342532

Collaborator

(none)

112

Enrollment

Location

Arms

30.7

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Amoxicillin Drug: Omeprazole Drug: Clarithromycin	Phase 4

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 12, 2019

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

Eradication rate [end of study at 6 weeks]
The eradication rate of high dose dual therapy vs clarithromycin triple therapy after treatment.

Secondary Outcome Measures

Number of participants with protocol specific adverse events [end of study at 6 weeks]
Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia
Number of participants completing at least 90% of all prescribed medications [end of study at 6 weeks]
Patients were provided a medication log to self-report drug compliance. After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.