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

S

St.Paul's Hospital, Korea

Status and phase

Completed
Phase 4

Conditions

H.Pylori Gastrointestinal Disease

Treatments

Other: Duration of HP therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02487511
HPTX Duration

Details and patient eligibility

About

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.

Full 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).

Enrollment

387 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

387 participants in 2 patient groups

14 days
Active Comparator group
Description:
14 days treatment regimen
Treatment:
Other: Duration of HP therapy
7 days
No Intervention group
Description:
7 days treatment regimen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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