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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011963
Receipt No. R000013976
Scientific Title Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between refabutin-including 10 days and 14 days regimen
Date of disclosure of the study information 2013/10/04
Last modified on 2016/04/06

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Basic information
Public title Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between refabutin-including 10 days and 14 days regimen
Acronym Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy
Scientific Title Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between refabutin-including 10 days and 14 days regimen
Scientific Title:Acronym Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy
Region
Japan

Condition
Condition H. pylori-positve patients after the 2nd line eradication failure
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of H. pylori eradication rates for 10 days or 14 days regimen with RBT, AMPC and PPI.
Basic objectives2 Others
Basic objectives -Others MIC of RBT, AMPC, rpoB 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 esomeprazole 80mg, q.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d.
10 days
Interventions/Control_2 esomeprazole 80mg, q.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d.
14 days
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 with informed consent
Key exclusion criteria 1. Patients with allergy for rifamycins
2. Patients with past histry of tuberculosis or nontuberculous mycobacterial infection
3. Patients with allergy for PPIs
4. Patients with allergy for penicillin
5. Patients with severe liver injury and/or severe renal damage
6. Pregnancy or possible pregnancy
7. Patients who are taking voriconazole
8. Patients with uveitis
9. Patients who were recognized as inappropriate for entry
Target sample size 170

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 masaoka@z6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Suzuki
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, SHinjuku-ku, Tokyo
TEL 070-6946-1119
Homepage URL http://www.keio-med.jp/gastro/index.html
Email masaoka@z6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially 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
2013 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 04 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
2013 Year 10 Month 04 Day
Last modified on
2016 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013976

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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