Status:

COMPLETED

High Dose PPI Triple Therapy Versus Sequential Therapy for Helicobacter Pylori Eradication

Lead Sponsor:

Mahidol University

Collaborating Sponsors:

Takeda Pharmaceuticals International, Inc.

Conditions:

Dyspepsia

Helicobacter-associated Gastritis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to compare the efficacy between 1-day high dose PPI-based triple therapy vs. 10-day sequential therapy for Helicobacter pylori eradication in functional dyspepsia patients...

Detailed Description

Background: Helicobacter pylori (HP) play an important role in the pathogenesis of chronic gastritis, peptic ulcer diseases as well as gastric cancer. Helicobacter pylori eradication is a critical st...

Eligibility Criteria

Inclusion

  • Functional dyspepsia patients (Rome III) with rapid urease test positive
  • Age ≥ 18 years old
  • No history of HP eradication

Exclusion

  • Recent use of PPI, H2RA, NSAID, Antibiotics within 2 weeks
  • Currently use of anticoagulants or ketoconazole
  • C/I for gastric biopsy
  • History of gastric surgery
  • Comorbidity: ESRD, advanced cirrhosis, AIDS, stroke (bed ridden)
  • Pregnancy or lactation
  • Allergy to studied drugs

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2014

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT01888237

Start Date

May 1 2013

End Date

September 1 2014

Last Update

April 10 2015

Active Locations (1)

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1

Division of gastroenterology, Department of Medicine, Siriraj hospital

Bangkok Noi, Bangkok, Thailand, 10700