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

Helicobacter Pylori Infection Clinical Trial

Official title:

Additive Effect of Endonase on the Efficacy of Bismuth-containing Quadruple Therapy as Second-line Treatment for Helicobacter Pylori Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01643785
• Other study ID #: CSHH Endonase2
• Status: Terminated
• Phase: N/A
• First received: July 11, 2012
• Last updated: January 20, 2014
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Second-line quadruple therapy with endonase
Compare Second-line quadruple therapy w/o pronase (endonase)

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks	No
Secondary	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	4 weeks	Yes
Secondary	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	4 weeks	No