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

This study is currently recruiting participants.
Verified July 2012 by Chuncheon Sacred Heart Hospital
Sponsor:
Information provided by (Responsible Party):
Yeonsoo Kim, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01645761
First received: July 16, 2012
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Helicobacter Pylori Associated Peptic Ulcer
 Drug: Endonase

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Chuncheon Sacred Heart Hospital:

Primary Outcome Measures:
  • Eradication rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment


Estimated Enrollment: 216
Study Start Date: June 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645761

Contacts
Contact: JinBong Kim, MD 82-33-240-5811 jinbkim@hallym.ac.kr
Contact: Yeonsoo Kim, MD 82-33-240-5643 kimyeonsoo@hallym.or.kr

Locations
Korea, Republic of
Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Gangwon, Korea, Republic of, 200-100
Contact: Jinbong Kim, MD     82-33-240-5811     jinbkim@hallym.ac.kr    
Contact: Yeonsoo Kim, MD     82-33-240-5643     kimyeonsoo@hallym.or.kr    
Principal Investigator: Jinbong Kim, MD            
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
  More Information

No publications provided

Responsible Party: Yeonsoo Kim, Assistant Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01645761     History of Changes
Other Study ID Numbers: CSHH Endonase 1, CLDD 1
Study First Received: July 16, 2012
Last Updated: July 18, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chuncheon Sacred Heart Hospital:
Helicobacter pylori eradication
Peptic ulcer

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Stomach Diseases
Pathologic Processes
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013