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Completed

NCT Number: NCT02159976

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea. 2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.

In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female Korean Adult (Aged ≥ 18 years)
  • Patients who diagnosis of H. pylori infection by any of following three methods
  • positive rapid urease test (CLOtest)
  • histologic evidence of H. pylori by modified Giemsa staining
  • positive 13C-urea breath test

Exclusion criteria

  • Age under 18 years
  • Previous eradication treatment for H. pylori
  • Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
  • History of gastrectomy
  • Advanced gastric cancer or other malignancy
  • Abnormal liver function or liver cirrhosis
  • Abnormal renal function or chronic kidney disease
  • Other severe concurrent diseases
  • Previous allergic reactions to the study drugs
  • Pregnant or lactating women

Treatment and study plan

Pantoprazole

Drug

Pantoprazole 40mg bid

Amoxicillin

Drug

Amoxicillin 1000mg bid

Clarithromycin

Drug

Clarithromycin 500mg bid

Metronidazole

Drug

Metronidazole 500mg tid

Tetracycline

Drug

Tetracycline 1000mg bid

Bismuth

Drug

Bismuth 600mg bid

Primary outcomes

  1. Counts of Participants With Successful H. Pylori Eradication

    Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks

Secondary outcomes

  1. Counts of Participants Whose Drug Compliance is More Than 85%

    Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks

  2. Counts of Participants With Adverse Event

    Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks

  3. Functional Dyspepsia Symptom Responses Rate

    Time frame: 1 year after termination of eradication therapy

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Chong Kun Dang Pharmaceutical
  • Green Cross Corporation
  • HK inno.N Corporation
  • SK Chemicals Co., Ltd.

Registry information

Official study title

A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 10, 2014
Registry last updated
May 13, 2019

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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