NCT05342532

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

Completed Phase 4 Results posted Last updated 1 February 2023

What this trial tests

Phase 4 trial testing Amoxicillin in Helicobacter Pylori Infection in 112 participants. Completed in 1 January 2022.

Timeline

12 June 2019

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	12 June 2019
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Amoxicillin (amoxicillin) — full drug profile →
• Omeprazole (omeprazole) — full drug profile →
• Clarithromycin (clarithromycin) — full drug profile →

Conditions studied

• Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participant With Eradication of Disease Primary · end of study at 6 weeks

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

Group	Value	95% CI
High Dose Dual Therapy	37
Standard Triple Therapy	42

Number of Participants With Protocol Specific Adverse Events Secondary · 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

Group	Value	95% CI
High Dose Dual Therapy	5
Standard Triple Therapy	20

Number of Participants Completing at Least 90% of All Prescribed Medications Secondary · 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).

Group	Value	95% CI
High Dose Dual Therapy	58
Standard Triple Therapy	54

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Dose Dual Therapy

Serious: 0/58 (0%)

Deaths: 0/58

Standard Triple Therapy

Serious: 0/54 (0%)

Deaths: 0/54

Other adverse events (6 terms — click to expand)

Reaction	System	High Dose Dual Therapy	Standard Triple Therapy
Abdominal pain	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Dysguesia	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT05342532 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.