Gastric Ulcer Associated With Helicobacter Pylori
Conditions
Keywords
Helicobacter pylori eradication, Peptic ulcer
Brief summary
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.
Interventions
DRUGEndonase
PPI- based triple therapy with endonase
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or Female with 18 years or more of age without history of H. pylori eradication AND 1. Patients with H. pylori associated peptic ulcer in scar stage, OR 2. Non-ulcer dyspepsia patients with H. pylori infection
Exclusion criteria
1. Under 18 years, OR 2. Patients with a history of previous treatment of H. pylori infection, OR 3. Pregnant or Breast feeding women, OR 4. Patients with severe renal, liver, or heart disease, OR 5. Patients with gastric malignancy, OR 6. Patients with a history of drug allergy or hypersensitivity, OR 7. Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate | 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 4 weeks | Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment |
| Number of participants taking over 85% of medicine | 4 weeks | Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment |
Countries
South Korea
Outcome results
None listed