One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL
NCT ID: NCT05728424
Last Updated: 2023-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
246 participants
INTERVENTIONAL
2022-09-20
2023-05-01
Brief Summary
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2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.
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Detailed Description
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H. pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important.
Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2 weeks vonoprazan containing triple regimen
For two weeks:
Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily
Vonoprazan, Amoxicillin, Levofloxacin
No additional information
1 week vonoprazan containing triple regimen
For One week:
Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily
For the second week:
Placebo
Vonoprazan, Amoxicillin, Levofloxacin
No additional information
Interventions
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Vonoprazan, Amoxicillin, Levofloxacin
No additional information
Eligibility Criteria
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Inclusion Criteria
* 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
* chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
* known renal and/or liver failure
* no known malignancy
* varices bleeding
18 Years
ALL
No
Sponsors
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Searle Pharmaceuticals
UNKNOWN
Aga Khan University
OTHER
Responsible Party
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SHAHAB ABID
Professor Of Medicine
Locations
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Aga Khan University Hospital
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-7002-21047
Identifier Type: -
Identifier Source: org_study_id
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