Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

February 23, 2016 updated by: Sung min, Park, Incheon St.Mary's Hospital

Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea

Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

single center, randomized trial

  1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
  2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
  3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
  4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days

1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Bupyung
      • Incheon, Bupyung, Korea, Republic of, KSXX0009
        • Recruiting
        • Incheon St.Mary hospital
        • Contact:
          • Sungmin Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20~80 patients
  • agreement of informed consent
  • H.pylori positive (biopsy, CLO)
  • Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer

Exclusion Criteria:

  • H.pylori eradication history
  • severe hepatic, renal, cardiac failure
  • pregnancy, participant of other study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequential therapy 10 days
1.(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 5 days
Drug: Sequential therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg ) bid for the next 5 days : Sequential therapy 1
ACTIVE_COMPARATOR: Sequential therapy 14 days
(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days
Drug: Sequential therapy 14 days
(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days : Sequential therpay 2
ACTIVE_COMPARATOR: Concomitant therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days
Drug: Concomitant therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1
ACTIVE_COMPARATOR: Concomitant therapy 14 days
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days
Drug: Concomitant therapy 14 days
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
Time Frame: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit
To assess Helicobacter pylori eradication rates
required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incheon St.Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

April 5, 2014

First Posted (ESTIMATE)

April 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSungmin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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