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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02557932
Other study ID # NCC2015-0207
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2015
Est. completion date September 28, 2019

Study information

Verified date April 2020
Source National Cancer Center, Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this randomized controlled trial, we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H. pylori.


Description:

Current Helicobacter pylori management guidelines recommend proton-pump inhibitor (PPI)-Clarithromycin containing triple therapy as 1st line treatment. However, in Korea, eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80% due to increased clarithromycin resistance. In areas of high clarithromycin resistance (resistance rate more than 15%), guidelines recommend bismuth quadruple therapy as a 1st line treatment for H. pylori eradication. Clarithromycin resistance rates reported from 15.7% to 42.1% in Korea, thus, bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy. However, only one limited study was performed to compare effects of the both treatment regimens in Korea. Thus, studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H. pylori infection.


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date September 28, 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men and women aged 18 or more including following conditions

- Family history of gastric cancer

- Post endoscopic resection status for early gastric cancer or adenoma

- Peptic ulcer disease (benign gastric ulcer and duodenal ulcer)

- Chronic gastritis

- Non-ulcer dyspepsia

- Healthy adults who want to receive H. pylori treatment

- H. pylori positive by urea breath test, histology, or rapid urease test

Exclusion Criteria:

- History of H. pylori eradication therapy

- History of stomach operation

- Other organ cancer within 5 years

- Liver cirrhosis or Hepatic insufficiency

- Renal insufficiency

- Current treatment for serious medical condition which may hinder participation

- Contraindication or allergy history for H. pylori treatment regimens

- Mental incompetence to understand and sign informed consent

- Incompatible conditions to be included into the trial by investigators' decision

- Inability to provide an informed consent

- History of treatment for peptic ulcer disease

Study Design


Intervention

Drug:
Standard triple therapy
Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
Bismuth quadruple therapy
Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days

Locations

Country Name City State
Korea, Republic of National Cancer Center Goyang Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary H. pylori eradication rate 8 weeks after H. pylori treatment
Secondary Complications of H. pylori treatment 1 month after H. pylori treatment
Secondary Compliance to H. pylori treatment 1 month
Secondary H. pylori infection status at 1 year after H. pylori treatment 1 year after H. pylori treatment
Secondary H. pylori reinfection rate 3 years after success of H. pylori eradication
Secondary Factors associated with H. pylori reinfection 3 years after success of H. pylori treatment
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