Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparison of 7-day Proton Pump Inhibitor (PPI)-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557932
• Other study ID #: NCC2015-0207
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Family History of Stomach Cancer
• Helicobacter Pylori Infection
• Stomach Neoplasms

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