UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013195
Receipt number R000015386
Scientific Title The efficacy and safety of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI
Date of disclosure of the study information 2014/02/18
Last modified on 2017/09/02 10:07:16

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Basic information

Public title

The efficacy and safety of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI

Acronym

The efficacy of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI

Scientific Title

The efficacy and safety of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI

Scientific Title:Acronym

The efficacy of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI

Region

Japan


Condition

Condition

H. pylori-positve patients after the 2nd line eradication failure or penicillin-allergic patients

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaliation of the efficacy and safety of STFX+MNZ+PPI 10days regimen

Basic objectives2

Others

Basic objectives -Others

The pre-eradication MIC of STFX, AMPC, The gyrA mutation

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

The efficacy of H. pylori eradication

Key secondary outcomes

adverse events
MIC of STFX,MNZ, gyaA mutation


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

esomeprazole 40mg,b.i.d., metronidazole 500mg b.i.d., q.i.d., sitafloxacin 200 mg, b.i.d.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

H. pylori-positve patients after the 2nd line H. pylori eradication therapy or penicillin-allergic patients

Key exclusion criteria

1. Patients with allergy for quinolones
2. Patients with allergy for PPIs
3. Patients with severe liver injury and/or severe renal damage
4. Pregnancy or possible pregnancy
5. Patients who were recognized as inappropriate for entry

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidekazu Suzuki

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code


Address

35 Shinanomachi, SHinjuku-ku, Tokyo

TEL

0353633914

Email

hsuzuki@a6.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Mori

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code


Address

35 Shinanomachi, SHinjuku-ku, Tokyo

TEL

070-6946-1119

Homepage URL

http://web.sc.itc.keio.ac.jp/medicine/PYLORI/small/index.html

Email

koyamaru2002@yahoo.co.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

慶應義塾大学医学部


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 02 Month 18 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 18 Day

Last modified on

2017 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name