Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation Health Condition 2: K299- Gastroduodenitis, unspecified
Conditions
Interventions
Intervention1: Vonoprazan (20 mg) + amoxicillin (1 g)
: Vonoprazan twice daily and amoxicillin thrice daily Orally for two weeks (14 Days).
Control Intervention1: Clarithromycin (500 mg) + amoxicil
Sponsors
Dr Sanjay Bandyopadhyay
Eligibility
Inclusion criteria
Inclusion criteria: 1Patients must voluntarily sign and date a patient authorization to use and or disclose his or her anonymized health data prior to inclusion into the study 2Male or Female patients more than equal to 18 years of age at the time of informed consent signing 3Patient has at least one of the following clinical conditions with confirmed H. pylori infection demonstrated by a positive RUT on biopsy samples during the Screening Period a Dyspepsia pain or discomfort centered in the upper abdomen lasting at least 2 weeks b A confirmed diagnosis of functional dyspepsia c A recent or new diagnosis of non bleeding peptic ulcer d A history of peptic ulcer not previously treated for H pylori infection 4Treatment with either oral vonoprazan plus amoxicillin or triple therapy with oral clarithromycin plus amoxicillin plus PPI, as determined by the patients treating physician in accordance with the approved prescribing information or package insert 5Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter
Exclusion criteria
Exclusion criteria: 1Patient has previously been treated with any regimen to attempt to eradicate H pylori 2Pregnant or lactating women 3The subject has a history of hypersensitivity or allergies to vonoprazan PPIs, clarithromycin, or amoxicillin 4Patient has confirmed diagnosis of gastric cancer by biopsy 5Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease 6Constant use of antiulcer drugs including taking PPI within 2 weeks before the RUT, antibiotics or bismuth complexes more than 3 times per 1 month before screening 7Patients diagnosed with gastroduodenal ulcers due to non H pylori causes, and mucosa associated lymphoid tissue lymphoma 8Patient underwent upper gastrointestinal Surgery 9Evidence of bleeding or iron efficiency anemia 10Patients with cutaneous lupus erythematosus or systemic lupus erythematosus 11Patients with acute tubulointerstitial nephritis 12Systemic use of corticosteroids, non steroidal anti inflammatory drugs, anticoagulants, platelet aggregation inhibitors except the use of aspirin for less than 100 mg per day 13Patient who has psychological problem or poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with successful H pylori eradication after the Treatment Period, as determined by RUT on biopsy samples, at 4 weeks after the last dose of study drug, in subjects who do not have a clarithromycin or amoxicillin resistant strain of H pylori at baselineTimepoint: At baseline and at 4th week after the last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting incidences of AE and or SAE during the study and their assessment in respect to intensity, duration, pattern, and causal relationship to the study medication. Timepoint: Throughout the study;Change from baseline to end of treatment in the requirement of rescue medication.Timepoint: Day 1 to End of Treatment;Global tolerability assessment by patients and investigators at the end of the treatment on a 3-point scale ranging from good tolerability (side effects may be mild or not observed) to poor tolerability (side effects severe or warranting/needing discontinuation).Timepoint: End of Treatment.;Changes in vital signs from baseline to end of the study.Timepoint: From baseline to end of the study.;Co-morbidities and concomitant medication.Timepoint: From baseline to end of the study.;Health related quality of life assessed using the SF-36 questionnaire.Timepoint: Baseline and at 4 weeks after the last dose of study drug. | — |
Countries
India
Contacts
Public ContactDr Sanjay Bandyopadhyay
Kolkata Gastro Care
Outcome results
None listed