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

Primary Purpose

Gastric Ulcer Associated With Helicobacter Pylori

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endonase
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Ulcer Associated With Helicobacter Pylori focused on measuring Helicobacter pylori eradication, Peptic ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chuncheon Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PPI-based triple therapy with endonase

PPI-based triple therapy

Arm 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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
July 16, 2012
Last Updated
January 20, 2014
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01645761
Brief Title
Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
Official Title
Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer Associated With Helicobacter Pylori
Keywords
Helicobacter pylori eradication, Peptic ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPI-based triple therapy with endonase
Arm Type
Experimental
Arm 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.
Arm Title
PPI-based triple therapy
Arm Type
No Intervention
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Endonase
Intervention Description
PPI- based triple therapy with endonase
Primary Outcome Measure Information:
Title
Eradication rate
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment
Time Frame
4 weeks
Title
Number of participants taking over 85% of medicine
Description
Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Bong Kim, MD
Organizational Affiliation
Department of Internal Medicine, Hallym university college of medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yeon Soo Kim, MD, PhD.
Organizational Affiliation
Department of Internal Medicine, Hallym University College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chang Seok Bang, MD
Organizational Affiliation
Department of Internal Medicine, Hallym University of College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon
ZIP/Postal Code
200-100
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25167799
Citation
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.
Results Reference
derived

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

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