UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012091
Receipt number R000014128
Scientific Title Treatment of H. pylori Infection for Resistance of Double eradications
Date of disclosure of the study information 2015/10/21
Last modified on 2015/10/21 14:33:17

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Basic information

Public title

Treatment of H. pylori Infection for Resistance of Double eradications

Acronym

Third Line Eradication Study (THIRD study)

Scientific Title

Treatment of H. pylori Infection for Resistance of Double eradications

Scientific Title:Acronym

Third Line Eradication Study (THIRD study)

Region

Japan


Condition

Condition

The patients after unseccessful 1st and 2nd line eradication treatment

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To find standard 3rd-line eradication regimen for H. pylori infection in Japan

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

Eradication rate at 1 to 3 months after eradication treatment

Key secondary outcomes

side effect


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

LPZ 30mg bid + AMPC 750mg bid + STFX 100mg bid (1W)

Interventions/Control_2

LPZ 30mg bid + AMPC 750mg bid + STFX 100mg bid (2W)

Interventions/Control_3

LPZ 30mg bid + MNZ 500mg bid + STFX 100mg bid (1W)

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients after failure of 1st-line eradcation (PPI+AMPC+CAM) and 2nd-line eradcation (PPI+AMPC+MNZ)

Key exclusion criteria

a history of antimicrobials after 2nd-line eradcation
a history of PPI use 1 week before entry a history of NSAID or steriod use 1 month before entry
a history of gastrointestinal surgery,
the severe liver, renal, and cardiopulmonary dysfunctions
a history of drug allergy

Target sample size

234


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mototsugu KATO

Organization

Hokkaido University Hospital

Division name

Division of Endoscopy

Zip code


Address

N-14, W-5, Kita-ku, Sapporo, 060-8468, Japan

TEL

011-716-1161

Email

m-kato@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mototsugu KATO

Organization

Hokkaido University Hospital

Division name

Division of Endoscopy

Zip code


Address

N-14, W-5, Kita-ku, Sapporo, 060-8468, Japan

TEL

011-716-1161

Homepage URL

http://www.sgics.jp/

Email

m-kato@med.hokudai.ac.jp


Sponsor or person

Institute

SAMURAI Study

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

大分医科大学等 他25施設


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2013 Year 05 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 21 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 08 Month 20 Day

Date trial data considered complete

2015 Year 09 Month 30 Day

Date analysis concluded

2015 Year 10 Month 20 Day


Other

Other related information



Management information

Registered date

2013 Year 10 Month 21 Day

Last modified on

2015 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014128


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name