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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001558
Receipt No. 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

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

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
URL(English) https://upload.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


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