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

NCT05342532 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY-19-01590
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

high-dose dual therapy; standard triple therapy; helicobacter pylori eradication; clarithromycin resistance

Outcome Measures

Primary Outcomes (1)

• Number of Participant With Eradication of Disease

  The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.

  end of study at 6 weeks

Secondary Outcomes (2)

• Number of Participants With Protocol Specific Adverse Events

  end of study at 6 weeks

• Number of Participants Completing at Least 90% of All Prescribed Medications

  end of study at 6 weeks

Study Arms (2)

High Dose Dual Therapy

ACTIVE COMPARATOR

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

Drug: Amoxicillin; Drug: Omeprazole

Standard triple therapy

ACTIVE COMPARATOR

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; Drug: Omeprazole; Drug: Clarithromycin

Interventions

Amoxicillin DRUG

1 g

High Dose Dual Therapy; Standard triple therapy

Omeprazole DRUG

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

High Dose Dual Therapy; Standard triple therapy

Clarithromycin DRUG

500 mg twice daily

Standard triple therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Union Square Division of Digestive Diseases

New York, New York, 10003, United States

Location

MeSH Terms

Interventions

Amoxicillin; Omeprazole; Clarithromycin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Gres Karim
• Organization: Icahn School of Medicine at Mount Sinai

gres.karim@mountsinai.org

212-241-2499

Study Officials

• Ilan Weisberg, MD, MSc

  Mount Sinai Beth Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 22, 2022
• Study Start: June 12, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 1, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-01-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

Locations

US (1)