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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | 1 g |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant With Eradication of Disease | The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment. | end of study at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | end of study at 6 weeks |
| Number of Participants Completing at Least 90% of All Prescribed Medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilan Weisberg, MD, MSc | Mount Sinai Beth Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Union Square Division of Digestive Diseases | New York | New York | 10003 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Immediately following publication. No end date.
Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Dual Therapy | This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. |
| FG001 | Standard Triple Therapy | This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. Clarithromycin: 500 mg twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Dual Therapy | This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participant With Eradication of Disease | The number of participants with eradication after high dose dual therapy vs clarithromycin triple therapy after treatment. | Posted | Count of Participants | Participants | end of study at 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose Dual Therapy | This regimen includes a 14-day course of amoxicillin 1 g three times daily and omeprazole 40 mg three times daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gres Karim | Icahn School of Medicine at Mount Sinai | 212-241-2499 | gres.karim@mountsinai.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2019 | Dec 27, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D009853 | Omeprazole |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Omeprazole |
| Drug |
40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. |
|
| Clarithromycin | Drug | 500 mg twice daily |
|
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). |
| end of study at 6 weeks |
| Standard Triple Therapy |
This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. Clarithromycin: 500 mg twice daily |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | end of study at 6 weeks |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | end of study at 6 weeks |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 5 |
| 58 |
| EG001 | Standard Triple Therapy | This regimen includes a 14-day course of clarithromycin 500 mg twice daily, omeprazole 40 mg twice daily, and amoxicillin 1g twice daily. Amoxicillin: 1 g Omeprazole: 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals. Clarithromycin: 500 mg twice daily | 0 | 54 | 0 | 54 | 20 | 54 |
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Dysguesia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |