Phase 4
N=112
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT05342532 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participant With Eradication of Disease — 37; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amoxicillin (Drug); Omeprazole (Drug); Clarithromycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant With Eradication of Disease |
37; 42 | — |
| SECONDARY Number of Participants With Protocol Specific Adverse Events |
5; 20 | — |
| SECONDARY Number of Participants Completing at Least 90% of All Prescribed Medications |
58; 54 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05342532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.