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

Helicobacter Pylori Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159976
• Other study ID #: B-1403/243-003
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: February 2019
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Pantoprazole
Pantoprazole 40mg bid
• Amoxicillin
Amoxicillin 1000mg bid
• Clarithromycin
Clarithromycin 500mg bid
• Metronidazole
Metronidazole 500mg tid
• Tetracycline
Tetracycline 1000mg bid
• Bismuth
Bismuth 600mg bid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Chong Kun Dang Pharmaceutical, CJ HealthCare Corporation, Green Cross Corporation, SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Counts of Participants With Successful H. Pylori Eradication		4 weeks after termination of eradication therapy, up to 6 weeks
Secondary	Counts of Participants Whose Drug Compliance is More Than 85%		4 weeks after termination of eradication therapy, up to 6 weeks
Secondary	Counts of Participants With Adverse Event		4 weeks after termination of eradication therapy, up to 6 weeks
Secondary	Functional Dyspepsia Symptom Responses Rate		1 year after termination of eradication therapy