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

Sponsor
Chuncheon Sacred Heart Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01643785
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Second-line quadruple therapy with endonase
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Additive Effect of Endonase on the Efficacy of Bismuth-containing Quadruple Therapy as Second-line Treatment for Helicobacter Pylori Infection
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: with Endonase

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

Drug: Second-line quadruple therapy with endonase
Compare Second-line quadruple therapy w/o pronase (endonase)
Other Names:
  • Brand name: Endonase

    		•
    No Intervention: without Endonase

    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

    Outcome Measures

    Primary Outcome Measures

    1. Eradication rate [4 weeks]

      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

    1. Number of participants with adverse events [4 weeks]

      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

    2. Number of participants taking over 85% of medicine [4 weeks]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chuncheon Sacred Heart Hospital Chuncheon Gangwon Korea, Republic of 200-100

    Sponsors and Collaborators

    • Chuncheon Sacred Heart Hospital

    Investigators

    • Principal Investigator: JinBong Kim, MD, Chuncheon Sacred Heart Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yeonsoo Kim, Assistant Professor, Chuncheon Sacred Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT01643785
    Other Study ID Numbers:
    • CSHH Endonase2
    First Posted:
    Jul 18, 2012
    Last Update Posted:
    Jan 22, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Yeonsoo Kim, Assistant Professor, Chuncheon Sacred Heart Hospital
    therapeutic efficacy endonase addictive effect
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Helicobacter Infections

    Study Results

    No Results Posted as of Jan 22, 2014