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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Ulcer Associated With Helicobacter Pylori
• Intervention / Treatment: Drug: Endonase

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon
    • Chuncheon, Gangwon, Korea, Republic of, 200-100
      • Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPI-based triple therapy with endonase; 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; PPI- based triple therapy with endonase
No Intervention: PPI-based triple therapy; 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?

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

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Investigators: Study Chair: Jin Bong Kim, MD, Department of Internal Medicine, Hallym University College of Medicine; Study Director: Yeon Soo Kim, MD, PhD., Department of Internal Medicine, Hallym University College of Medicine; Principal Investigator: Chang Seok Bang, MD, Department of Internal Medicine, Hallym University of College of Medicine

Publications and helpful links

General Publications

• Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ. Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection. Gut Liver. 2015 May 23;9(3):340-5. doi: 10.5009/gnl13399.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Peptic ulcer; Helicobacter pylori eradication
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Stomach Ulcer
• Other Study ID Numbers: CSHH Endonase 1; CLDD 1 (Other Identifier: CSHH CLDD 1)