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

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

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

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole; Drug: Tetracycline; Drug: Bismuth

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequential therapy; pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)	Drug: Pantoprazole; Pantoprazole 40mg bid; Drug: Amoxicillin; Amoxicillin 1000mg bid; Drug: Clarithromycin; Clarithromycin 500mg bid; Drug: Metronidazole; Metronidazole 500mg tid
Experimental: Modified bismuth quadruple therapy; pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)	Drug: Pantoprazole; Pantoprazole 40mg bid; Drug: Amoxicillin; Amoxicillin 1000mg bid; Drug: Tetracycline; Tetracycline 1000mg bid; Drug: Bismuth; Bismuth 600mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Counts of Participants With Successful H. Pylori Eradication	4 weeks after termination of eradication therapy, up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Counts of Participants Whose Drug Compliance is More Than 85%	4 weeks after termination of eradication therapy, up to 6 weeks
Counts of Participants With Adverse Event	4 weeks after termination of eradication therapy, up to 6 weeks
Functional Dyspepsia Symptom Responses Rate	1 year after termination of eradication therapy

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Green Cross Corporation; Chong Kun Dang Pharmaceutical; SK Chemicals Co., Ltd.; HK inno.N Corporation

Publications and helpful links

General Publications

• Lee JY, Kim N, Park KS, Kim HJ, Park SM, Baik GH, Shim KN, Oh JH, Choi SC, Kim SE, Kim WH, Park SY, Kim GH, Lee BE, Jo Y, Hong SJ. Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial. BMC Gastroenterol. 2016 Jul 26;16(1):79. doi: 10.1186/s12876-016-0490-8.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Helicobacter pylori
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Metronidazole; Amoxicillin; Clarithromycin; Bismuth; Pantoprazole; Tetracycline
• Other Study ID Numbers: B-1403/243-003