Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy

H.Pylori Gastrointestinal Disease Clinical Trial

Official title:

Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487511
• Other study ID #: HPTX Duration
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2015
• Last updated: June 7, 2017
• Start date: August 1, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: June 2017
• Source: St.Paul's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.

This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.

Description:

The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.

The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: January 31, 2017
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Peptic ulcer including ulcer scar

• Early gastric cancer

• Gastric mucosa-associated lymphoid tissue lymphoma

Exclusion Criteria:

• operation history

• liver cirrhosis

• chronic kidney disease

• pregnancy

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• H.Pylori Gastrointestinal Disease

Intervention

Other:
• Duration of HP therapy
the comparison of HP eradication rate between 7 days and 14 days

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
St.Paul's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the comparison with 7days and 14days eradication rate of PPI based therapy		12 months after randomization
Secondary	the rate of side effects related to helicobacter eradication regimen		12 months after randomization