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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Yeonsoo Kim, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01643785
First received: July 11, 2012
Last updated: January 20, 2014
Last verified: January 2014
  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 the second-line eradication therapy against Helicobacter pylori.


Condition Intervention
Helicobacter Pylori Infection
Drug: Second-line quadruple therapy with 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 the Efficacy of Bismuth-containing Quadruple Therapy as Second-line Treatment for Helicobacter Pylori Infection

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 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643785

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Yeonsoo Kim, Assistant Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01643785     History of Changes
Other Study ID Numbers: CSHH Endonase2
Study First Received: July 11, 2012
Last Updated: January 20, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chuncheon Sacred Heart Hospital:
therapeutic efficacy endonase addictive effect

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Infection
Bacterial Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 19, 2014