NCT01573975

Brief Summary

The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Typical duration for phase_4

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

January 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

April 4, 2012

Last Update Submit

April 9, 2012

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriantibiotic resistancesequential therapyTaiwan

Outcome Measures

Primary Outcomes (1)

  • Eradication rate

    A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment

    4 weeks after complete use of drug for treatment

Study Arms (3)

Seq-Metronidazole

EXPERIMENTAL

10-day sequential therapy with metronidazole

Drug: 5RA-5RCM

Seq-Tetracycline

EXPERIMENTAL

10-day sequential therapy with tetracycline.

Drug: 5RA-5RCT

Control

ACTIVE COMPARATOR

10-day standard triple therapy.

Drug: 10RCA

Interventions

5RA-5RCMDRUG

rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.

Also known as: Pariet x 10 days, Hiconcil x 1st 5 days then, Klaricid x last 5 days +, Flagyl x last 5 days
Seq-Metronidazole
5RA-5RCTDRUG

rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.

Also known as: Pariet x 10 days, Hiconcil x 1st 5 days then, Klaricid x last 5 days +, Acromycin x last 5 days.
Seq-Tetracycline
10RCADRUG

rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.

Also known as: Pariet x 10 days, Klaricid x 10 days, Hiconcil x 10 days.
Control

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient proved with infection of H. pylori in gastric mucosa
  • adult with signed inform consent

You may not qualify if:

  • woman in breast feeding or pregnancy.
  • allergy to drugs used in study.
  • three months without use of any antibiotic agents.
  • patients under 20 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, 97002, Taiwan

Location

Related Publications (4)

  • Graham DY, Abudayyeh S, El-Zimaity HM, Hoffman J, Reddy R, Opekun AR. Sequential therapy using high-dose esomeprazole-amoxicillin followed by gatifloxacin for Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Sep 1;24(5):845-50. doi: 10.1111/j.1365-2036.2006.03072.x.

    PMID: 16918889BACKGROUND

  • Jafri NS, Hornung CA, Howden CW. Meta-analysis: sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment. Ann Intern Med. 2008 Jun 17;148(12):923-31. doi: 10.7326/0003-4819-148-12-200806170-00226. Epub 2008 May 19.

    PMID: 18490667BACKGROUND

  • Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, Morini S. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):556-63. doi: 10.7326/0003-4819-146-8-200704170-00006.

    PMID: 17438314BACKGROUND

  • Choi WH, Park DI, Oh SJ, Baek YH, Hong CH, Hong EJ, Song MJ, Park SK, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. [Effectiveness of 10 day-sequential therapy for Helicobacter pylori eradication in Korea]. Korean J Gastroenterol. 2008 May;51(5):280-4. Korean.

    PMID: 18516011BACKGROUND

Study Officials

  • Ming-Cheh CHEN, MD

    Buddhist Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 10, 2012

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

TW(1)