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Completed

NCT Number: NCT05342532

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Union Square Division of Digestive Diseases

New York, 10003, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

1 g

Omeprazole

Drug

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

Clarithromycin

Drug

500 mg twice daily

Primary outcomes

  1. Number of Participant With Eradication of Disease

    Time frame: end of study at 6 weeks

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

Secondary outcomes

  1. Number of Participants With Protocol Specific Adverse Events

    Time frame: 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

  2. Number of Participants Completing at Least 90% of All Prescribed Medications

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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