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

Chuncheon Sacred Heart Hospital

Status: Completed

Conditions: Gastric Ulcer Associated With Helicobacter Pylori

Treatments: Drug: Endonase

Study type: Interventional

Funder types: Other

Identifiers

NCT01645761

CSHH Endonase 1

CLDD 1 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

PPI-based triple therapy with endonase

Experimental group

Description:

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.

Treatment:

Drug: Endonase

PPI-based triple therapy

No Intervention group

Description:

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)