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

Not Applicable

Terminated

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Second-line quadruple therapy with endonase

• Registration Number: NCT01643785
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with Endonase	Second-line quadruple therapy 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of