NCT01643785

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

Terminated NA Last updated 20 January 2014

What this trial tests

NA trial testing Second-line quadruple therapy with endonase in Helicobacter Pylori Infection in 30 participants. Terminated before completion.

Timeline

1 June 2012

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Chuncheon Sacred Heart Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 June 2012
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	1 location across South Korea

Drugs / interventions tested

• Second-line quadruple therapy with endonase — full drug profile →

Conditions studied

• Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →

Sponsor

Chuncheon Sacred Heart Hospital

Who can join

18 and older, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Eradication rate
  Time frame: 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. NLRP3 inflammasome in digestive diseases: From mechanism to therapy.
   Qiang R, Li Y, Dai X, Lv W. · · 2022 · cited 23× · PMID 36389791 · DOI 10.3389/fimmu.2022.978190