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

NCT01643785 | Terminated DMC

• 1 other identifier: CSHH Endonase2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

therapeutic efficacy endonase addictive effect

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of participants with adverse events

  4 weeks

• Number of participants taking over 85% of medicine

  4 weeks

Study Arms (2)

with Endonase

EXPERIMENTAL

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

without Endonase

NO INTERVENTION

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

Interventions

Second-line quadruple therapy with endonase DRUG

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

Also known as: Brand name: Endonase

with Endonase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori

You may not qualify if:

• Patients Under 18 years, OR
• Patients with active peptic ulcer, OR
• Pregnant or Breast feeding women, OR
• Patients with gastric malignancy, OR
• Patients with a history of drug allergy or hypersensitivity, OR
• Patients with severe renal, liver, or heart diseases

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 200-100, South Korea

Location

Study Officials

• JinBong Kim, MD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 18, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

KR (1)