High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amoxicillin
Omeprazole
Clarithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring high-dose dual therapy, standard triple therapy, helicobacter pylori eradication, clarithromycin resistance
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
Sites / Locations
- Mount Sinai Union Square Division of Digestive Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High Dose Dual Therapy
Standard triple therapy
Arm Description
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Outcomes
Primary Outcome Measures
Number of Participant With Eradication of Disease
The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
Secondary Outcome Measures
Number of Participants With Protocol Specific Adverse Events
Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia
Number of Participants Completing at Least 90% of All Prescribed Medications
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).
Full Information
NCT ID
NCT05342532
First Posted
April 19, 2022
Last Updated
January 6, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05342532
Brief Title
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 5, 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
high-dose dual therapy, standard triple therapy, helicobacter pylori eradication, clarithromycin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Dual Therapy
Arm Type
Active Comparator
Arm Description
This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily.
Arm Title
Standard triple therapy
Arm Type
Active Comparator
Arm Description
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
1 g
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
500 mg twice daily
Primary Outcome Measure Information:
Title
Number of Participant With Eradication of Disease
Description
The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
Time Frame
end of study at 6 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Protocol Specific Adverse Events
Description
Patient tolerability determined by adverse event rates noted by the presence of abdominal pain, diarrhea, dysgeusia, nausea, vomiting, dysphagia
Time Frame
end of study at 6 weeks
Title
Number of Participants Completing at Least 90% of All Prescribed Medications
Description
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).
Time Frame
end of study at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Weisberg, MD, MSc
Organizational Affiliation
Mount Sinai Beth Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Union Square Division of Digestive Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing 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).
Learn more about this trial
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
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