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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01643785

Enrollment

Registered

2012-07-18

Start date

2012-06-30

Completion date

2013-06-30

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

therapeutic efficacy endonase addictive effect

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.

Interventions

DRUGSecond-line quadruple therapy with endonase

Compare Second-line quadruple therapy w/o pronase (endonase)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026