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

July 16, 2012
July 18, 2012
June 2012
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01645761 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Pylori Associated Peptic Ulcer
Drug: Endonase
PPI- based triple therapy with endonase
  • 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.
    Intervention: Drug: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
216
Not Provided
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: JinBong Kim, MD 82-33-240-5811 jinbkim@hallym.ac.kr
Contact: Yeonsoo Kim, MD 82-33-240-5643 kimyeonsoo@hallym.or.kr
Korea, Republic of
 
NCT01645761
CSHH Endonase 1, CLDD 1
Yes
Yeonsoo Kim, Chuncheon Sacred Heart Hospital
Chuncheon Sacred Heart Hospital
Not Provided
Not Provided
Chuncheon Sacred Heart Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP