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OpenTrials
Completed

NCT Number: NCT01645761

Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori

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 eradication therapy against Helicobacter pylori.

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Key information

Conditions

Gastric Ulcer Associated With Helicobacter Pylori Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuncheon Sacred Heart Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or Female with 18 years or more of age without history of H. pylori eradication AND

  • Patients with H. pylori associated peptic ulcer in scar stage, OR
  • Non-ulcer dyspepsia patients with H. pylori infection

Exclusion criteria

  • Under 18 years, OR
  • Patients with a history of previous treatment of H. pylori infection, OR
  • Pregnant or Breast feeding women, OR
  • Patients with severe renal, liver, or heart disease, OR
  • Patients with gastric malignancy, OR
  • Patients with a history of drug allergy or hypersensitivity, OR
  • Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy

Treatment and study plan

Endonase

Drug

PPI- based triple therapy with endonase

Primary outcomes

  1. Eradication rate

    Time frame: 4 weeks

    Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple therapy

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: 4 weeks

    Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment

  2. Number of participants taking over 85% of medicine

    Time frame: 4 weeks

    Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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