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Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Second-line quadruple therapy with endonase
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring therapeutic efficacy endonase addictive effect

Eligibility Criteria

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

Inclusion Criteria:

Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori

Exclusion Criteria:

  1. Patients Under 18 years, OR
  2. Patients with active peptic ulcer, OR
  3. Pregnant or Breast feeding women, OR
  4. Patients with gastric malignancy, OR
  5. Patients with a history of drug allergy or hypersensitivity, OR
  6. Patients with severe renal, liver, or heart diseases

Sites / Locations

  • Chuncheon Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

with Endonase

without Endonase

Arm Description

Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] plus 20,000 units of pronase (endonase), BID for 7 days

Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] for 7 days

Outcomes

Primary Outcome Measures

Eradication rate
Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the bismuth-containing quadruple therapy plus endonase as the second-line treatment with that of the bismuth-containing quadruple therapy

Secondary Outcome Measures

Number of participants with adverse events
Difference in the number of participants with adverse events between patients receiving bismuth-containing quadruple therapy plus endoase as the second-line treatment for H. pylori and patients receiving only bismuth-containing quadruple therapy
Number of participants taking over 85% of medicine
Difference in the number of participants taking over 85% of medicine between patients receiving bismuth-containing quadruple therapy plus endoase as the second-line treatment for H. pylori and patients receiving only bismuth-containing quadruple therapy

Full Information

First Posted
July 11, 2012
Last Updated
January 20, 2014
Sponsor
Chuncheon Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01643785
Brief Title
Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection
Official Title
Additive Effect of Endonase on the Efficacy of Bismuth-containing Quadruple Therapy as Second-line Treatment for Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 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 the second-line eradication therapy against Helicobacter pylori.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
therapeutic efficacy endonase addictive effect

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
with Endonase
Arm Type
Experimental
Arm Description
Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] plus 20,000 units of pronase (endonase), BID for 7 days
Arm Title
without Endonase
Arm Type
No Intervention
Arm Description
Second-line quadruple therapy [PPI(pantoprazole 40mg, lansoprazole 30mg, esomeprazole 40mg, rabeprazole 20mg, omeprazole 20mg) Bid, tetracycline 500 mg QID, metronidazole 500mg Tid, tripotassium dicitrate bismuthate 300mg QID] for 7 days
Intervention Type
Drug
Intervention Name(s)
Second-line quadruple therapy with endonase
Other Intervention Name(s)
Brand name: Endonase
Intervention Description
Compare Second-line quadruple therapy w/o pronase (endonase)
Primary Outcome Measure Information:
Title
Eradication rate
Description
Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the bismuth-containing quadruple therapy plus endonase as the second-line treatment with that of the bismuth-containing quadruple 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 bismuth-containing quadruple therapy plus endoase as the second-line treatment for H. pylori and patients receiving only bismuth-containing quadruple therapy
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 bismuth-containing quadruple therapy plus endoase as the second-line treatment for H. pylori and patients receiving only bismuth-containing quadruple therapy
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori Exclusion Criteria: Patients Under 18 years, OR Patients with active peptic ulcer, OR Pregnant or Breast feeding women, OR Patients with gastric malignancy, OR Patients with a history of drug allergy or hypersensitivity, OR Patients with severe renal, liver, or heart diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JinBong Kim, MD
Organizational Affiliation
Chuncheon Sacred Heart Hospital
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

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Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection

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