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

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Mount Sinai Health System

Status and phase

Completed
Phase 4

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Omeprazole
Drug: Clarithromycin
Drug: Amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT05342532
STUDY-19-01590

Details and patient eligibility

About

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.

Full 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).

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

High Dose Dual Therapy
Active Comparator group
Description:
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Treatment:
Drug: Amoxicillin
Drug: Omeprazole
Standard triple therapy
Active Comparator group
Description:
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Treatment:
Drug: Amoxicillin
Drug: Clarithromycin
Drug: Omeprazole

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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