NCT02108184

Brief Summary

Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. single center, randomized trial

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

February 26, 2014

Last Update Submit

February 23, 2016

Conditions

Helicobacter Pylori Infection

Keywords

helicobacter eradication rates

Outcome Measures

Primary Outcomes (1)

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

    To assess Helicobacter pylori eradication rates

    required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit

Study Arms (4)

Sequential therapy 10 days

EXPERIMENTAL

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

Sequential therapy 14 days

ACTIVE COMPARATOR

(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

Concomitant therapy 10 days

ACTIVE COMPARATOR

(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days

Drug: Concomitant therapy 10 days

Concomitant therapy 14 days

ACTIVE COMPARATOR

(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days

Drug: Concomitant therapy 14 days

Interventions

Sequential therapy 10 daysDRUG

(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

Sequential therapy 10 days
Sequential therapy 14 daysDRUG

(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

Sequential therapy 14 days
Concomitant therapy 10 daysDRUG

(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1

Concomitant therapy 10 days
Concomitant therapy 14 daysDRUG

(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2

Concomitant therapy 14 days

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St.Mary hospital

Incheon, Bupyung, KSXX0009, South Korea

RECRUITING

Related Publications (2)

  • Lim JH, Lee DH, Choi C, Lee ST, Kim N, Jeong SH, Kim JW, Hwang JH, Park YS, Lee SH, Shin CM, Jo HJ, Jang ES, Song Is, Jung HC. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study. Helicobacter. 2013 Jun;18(3):180-6. doi: 10.1111/hel.12034. Epub 2013 Jan 11.

    PMID: 23305083BACKGROUND

  • Kim JS, Kim BW, Ham JH, Park HW, Kim YK, Lee MY, Ji JS, Lee BI, Choi H. Sequential Therapy for Helicobacter pylori Infection in Korea: Systematic Review and Meta-Analysis. Gut Liver. 2013 Sep;7(5):546-51. doi: 10.5009/gnl.2013.7.5.546. Epub 2013 Aug 14.

    PMID: 24073312RESULT

Central Study Contacts

Sung min Park

CONTACT

082-032-280-5052danson2000@hanmail.net

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
fellow

Study Record Dates

First Submitted

February 26, 2014

First Posted

April 9, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

KR(1)