NCT01888237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

June 25, 2013

Last Update Submit

April 9, 2015

Conditions

DyspepsiaHelicobacter-associated GastritisStomach Disorders

Keywords

DyspepsiaHelicobacter pyloriClarithromycin resistanceOther Specified Disorders of Function of Stomach

Outcome Measures

Primary Outcomes (1)

  • Eradication rate

    4 weeks after the end of intervention

Secondary Outcomes (3)

  • Adherence rate/adverse events

    up to 2 weeks after intervention initiation

  • Prevalence of clarithromycin resistance HP

    4 weeks after the end of intervention

  • Symptomatic responses regarding dyspeptic symptoms after HP eradication

    Baseline, week 4,8 and 24 after intervention completion

Study Arms (2)

Sequential therapy (ST)

ACTIVE COMPARATOR

10 day Sequential therapy: lansoprazole 30 mg b.d. plus amoxicillin 1000 mg b.d. for 5 days then lansoprazole 30 mg b.d., metronidazole 400 mg b.d. and clarithromycin 500 mg b.d. for the remaining 5 days

Drug: sequence of drug use

High dose PPI triple therapy(TT)

EXPERIMENTAL

10 day high dose PPI triple therapy: lansoprazole 60 mg b.d. plus clarithromycin 500 mg b.d. and amoxycillin 1000 mg b.d. for 10 days

Drug: Double dose of PPI

Interventions

Double dose of PPIDRUG

Lansoprasole (30mg) 2 tab oral BID

High dose PPI triple therapy(TT)
sequence of drug useDRUG

lansoprazole 30 mg b.d. for 10 days amoxicillin 1000 mg b.d. (day 1 to day 5) metronidazole 400 mg b.d. (day 6-day 10) and clarithromycin 500 mg b.d. (day 6-day 10)

Sequential therapy (ST)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of gastroenterology, Department of Medicine, Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Auesomwang C, Maneerattanaporn M, Chey WD, Kiratisin P, Leelakusolwong S, Tanwandee T. Ten-day high-dose proton pump inhibitor triple therapy versus sequential therapy for Helicobacter pylori eradication. J Gastroenterol Hepatol. 2018 Nov;33(11):1822-1828. doi: 10.1111/jgh.14292. Epub 2018 Jun 27.

    PMID: 29804294DERIVED

MeSH Terms

Conditions

DyspepsiaStomach Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • monthira maneerattanaporn

    Division of gastroenterology, Department of Medicine, Siriraj hospital 2, Pran-nok, Bangkoknoi, Bangkok, Thailand, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

TH(1)