Gastric Ulcer Associated With Helicobacter Pylori Clinical Trial
Official title:
Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori
| Verified date | January 2014 |
| Source | Chuncheon Sacred Heart Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon |
| Lead Sponsor | Collaborator |
|---|---|
| Chuncheon Sacred Heart Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | Yes |
| Secondary | 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 | No |