Clinical trial NCT02487511: Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
Official title: Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: H.Pylori Gastrointestinal Disease
Lead sponsor: St.Paul's Hospital, Korea
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 387
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: the comparison with 7days and 14days eradication rate of PPI based therapy
timeFrame: 12 months after randomization
Secondary outcomes:
measure: the rate of side effects related to helicobacter eradication regimen
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
Study officials:
affiliation: the Catholic Univerisity of Korea
name: JUNG HWAN Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim TH, Park JM, Cheung DY, Oh JH. Comparison of 7- and 14-Day Eradication Therapy for Helicobacter pylori with First- and Second-Line Regimen: Randomized Clinical Trial. J Korean Med Sci. 2020 Feb 10;35(5):e33. doi: 10.3346/jkms.2020.35.e33.