Helicobacter Pylori InfectionPhase 4NCT05342532
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
A Phase 4 study testing Amoxicillin, Omeprazole and Clarithromycin in people with Helicobacter Pylori Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Amoxicillin, Omeprazole and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 1 Jan 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Union Square Division of Digestive Diseases
New York, New York, 10003
About this study
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
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.
Read the 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).
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Amoxicillin, Omeprazole, Clarithromycin
- Keywords
- high-dose dual therapy, standard triple therapy, helicobacter pylori eradication, clarithromycin resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
1 g
OmeprazoleDrug
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.
ClarithromycinDrug
500 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| High Dose Dual Therapy | Active comparator | This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. Receives: Drug: Amoxicillin; Drug: Omeprazole |
| Standard triple therapy | Active comparator | This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Receives: Drug: Amoxicillin; Drug: Omeprazole; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant With Eradication of Disease
The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment.
Measured: end of study at 6 weeks
Secondary outcomes (2)
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
Measured: end of study at 6 weeks
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).
Measured: end of study at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start12 Jun 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilan S Weisberg, Icahn School of Medicine at Mount Sinai
- Investigators
- Ilan Weisberg, MD, MSc, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342532
- Sponsor's protocol ID
- STUDY-19-01590
- Status last verified
- 5 Jan 2023
- First submitted
- 19 Apr 2022
- Last updated
- 1 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05342532
- Acronym / sponsor ID
- STUDY-19-01590
- Conditions
- Helicobacter Pylori Infection
- Keywords
- high-dose dual therapy, standard triple therapy, helicobacter pylori eradication, clarithromycin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Dual Therapy | Active comparator | Drug: Amoxicillin, Drug: OmeprazoleThis regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. |
| Standard triple therapy | Active comparator | Drug: Amoxicillin, Drug: Omeprazole, Drug: ClarithromycinThis regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin1 g | Drug | High Dose Dual Therapy, Standard triple therapy |
| Omeprazole40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. | Drug | High Dose Dual Therapy, Standard triple therapy |
| Clarithromycin500 mg twice daily | Drug | Standard triple therapy |
Primary outcome
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.
2 secondary outcomes
Number of Participants With Protocol Specific Adverse Events
Time frame: end of study at 6 weeks
Number of Participants Completing at Least 90% of All Prescribed Medications
Time frame: end of study at 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Weisberg, MD, MSc principal investigator
Mount Sinai Beth Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin, Omeprazole and Clarithromycin in people with Helicobacter Pylori Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant With Eradication of Disease (time frame: end of study at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.