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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02487511
Enrollment
387
Registered
2015-07-01
Start date
2015-08-01
Completion date
2017-01-31
Last updated
2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H.Pylori Gastrointestinal Disease

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).

Interventions

OTHERDuration of HP therapy

the comparison of HP eradication rate between 7 days and 14 days

Sponsors

St.Paul's Hospital, Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the comparison with 7days and 14days eradication rate of PPI based therapy12 months after randomization

Secondary

MeasureTime frame
the rate of side effects related to helicobacter eradication regimen12 months after randomization

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026