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Clinical trial

ONE WEEK VS. TWO WEEKS VONOPRAZAN CONTAINING TRIPLE REGIMEN FOR ERADICATION OF HELICOBACTER PYLORI:

ID
Name
2022-7002-21047
Description
1. To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. 2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.
Trial arms
Trial start
2022-09-20
Estimated PCD
2023-04-01
Trial end
2023-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Vonoprazan, Amoxicillin, Levofloxacin
No additional information
Arms:
1 week vonoprazan containing triple regimen, 2 weeks vonoprazan containing triple regimen
Size
246
Primary endpoint
Efficacy of triple therapy in eradication of H.pylori (based on duration)
6 months
Eligibility criteria
Inclusion Criteria: * Age ≥ 18 years * H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen. Exclusion Criteria: * acute gastrointestinal disease (e.g., acute diarrhea) * chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease) * known renal and/or liver failure * no known malignancy * varices bleeding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 246, 'type': 'ESTIMATED'}}
Updated at
2023-02-15

1 organization

1 product

1 indication

Organization
Aga Khan University
Product
Vonoprazan
Indication
Helicobacter pylori infection