Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori

Study Overview
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Brief Summary
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Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.

Official Title
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Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori

Conditions
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Gastric Ulcer Associated With Helicobacter Pylori

Intervention / Treatment
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* Drug: Endonase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female with 18 years or more of age without history of H. pylori eradication AND Patients with H. pylori associated peptic ulcer in scar stage, OR Non-ulcer dyspepsia patients with H. pylori infection Exclusion Criteria: Under 18 years, OR Patients with a history of previous treatment of H. pylori infection, OR Pregnant or Breast feeding women, OR Patients with severe renal, liver, or heart disease, OR Patients with gastric malignancy, OR Patients with a history of drug allergy or hypersensitivity, OR Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPI-based triple therapy with endonase<br>7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) plus 20,000 units of endonase twice daily for one week. | Drug: Endonase<br>* PPI- based triple therapy with endonase<br>|
| No Intervention: PPI-based triple therapy<br>7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate | Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple therapy | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment | 4 weeks | 
| Number of participants taking over 85% of medicine | Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori eradication, Peptic ulcer