Clinical trial NCT05728424: One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL
Official title: ONE WEEK VS. TWO WEEKS VONOPRAZAN CONTAINING TRIPLE REGIMEN FOR ERADICATION OF HELICOBACTER PYLORI:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Searle Pharmaceuticals
First posted: 2023-02-15
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Introduction: The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms.

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.

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

Primary outcomes:
measure: Efficacy of triple therapy in eradication of H.pylori (based on duration)
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia)
timeFrame: 6 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References: