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Completed

NCT Number: NCT02487511

Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy

It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.

This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.

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Key information

Conditions

H.Pylori Gastrointestinal Disease

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Catholic University of Korea

Seoul, South Korea

About this study

The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.

The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Peptic ulcer including ulcer scar
  • Early gastric cancer
  • Gastric mucosa-associated lymphoid tissue lymphoma

Exclusion criteria

  • operation history
  • liver cirrhosis
  • chronic kidney disease
  • pregnancy

Treatment and study plan

Duration of HP therapy

Other

the comparison of HP eradication rate between 7 days and 14 days

Primary outcomes

  1. the comparison with 7days and 14days eradication rate of PPI based therapy

    Time frame: 12 months after randomization

Secondary outcomes

  1. the rate of side effects related to helicobacter eradication regimen

    Time frame: 12 months after randomization

Sponsors and collaborators

Lead sponsor

St.Paul's Hospital, Korea

Other

Registry information

Official study title

Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Jun 9, 2017

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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