UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001558
Receipt number R000001883
Scientific Title Third-line H. pylori eradication therapy with sitafloxacin-including regimen
Date of disclosure of the study information 2008/12/11
Last modified on 2014/05/09 13:16:00

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Basic information

Public title

Third-line H. pylori eradication therapy with sitafloxacin-including regimen

Acronym

H. pylori eradication therapy with sitafloxacin-including regimen

Scientific Title

Third-line H. pylori eradication therapy with sitafloxacin-including regimen

Scientific Title:Acronym

H. pylori eradication therapy with sitafloxacin-including regimen

Region

Japan


Condition

Condition

Patients with H. pylori eradication failure after the second-line regimen

Classification by specialty

Gastroenterology Psychosomatic Internal Medicine Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Application of sitafloxacin to third-line eradication therapy of H. pylori with the assessment of MIC, gyrA mutation of H. pylori.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Eradication rate of H. pylori by sitafloxacin-including regimen

Key secondary outcomes

MIC of sitafloxacin, gyrA mutation of H. pylori


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

H. pylori eradication therapy with sitafloxacin-including regimen

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

patients with H. pylori eradication failure after obtaining the informed consent.

Key exclusion criteria

penicillin or quinolone allergy
rabeprazole allergy
severe liver dysfunction, renal dysfunction
pregnancy or possibly pregnancy
cases with unsuitable recognition by doctors

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidekazu Suzuki, M.D., Ph.D.

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, 160-8582, Japan

TEL

03-5363-3914

Email



Public contact

Name of contact person

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, 160-8582, Japan

TEL

03-5363-3914

Homepage URL


Email

hsuzuki@sc.itc.keio.ac.jp


Sponsor or person

Institute

DIvision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Donation to the Department

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2008 Year 12 Month 11 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

Sitafloxacin-based triple therapy achieved 83.6% (per-protocol) and 78.2% (intention-to-treat) success in eradicating Helicobacter pylori among 78 Japanese patients after clarithromycin-based first-line and metronidazole-based second-line triple therapies failed. Eradication succeeded in 32 out of 43 patients, even with gyrA mutation-positive Helicobacter pylori (per protocol). The position of the gyrA mutation (N87 or D91) was determined to be a better marker than MIC levels for predicting outcomes of sitafloxacin-based treatment.

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

2008 Year 11 Month 22 Day

Date of IRB


Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry

2011 Year 09 Month 01 Day

Date trial data considered complete

2012 Year 02 Month 01 Day

Date analysis concluded

2012 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 12 Month 08 Day

Last modified on

2014 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name