UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007971 |
|---|---|
| Receipt number | R000009384 |
| Scientific Title | Efficacy of Helicobacter pylori eradication regimen based on antibiotic susceptibility testing in patients with multiple eradication failures |
| Date of disclosure of the study information | 2012/05/16 |
| Last modified on | 2016/09/20 22:25:03 |
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Basic information
Public title
Efficacy of Helicobacter pylori eradication regimen based on antibiotic susceptibility testing in patients with multiple eradication failures
Acronym
Efficacy of Helicobacter pylori eradication regimen based on antibiotic susceptibility testing
Scientific Title
Efficacy of Helicobacter pylori eradication regimen based on antibiotic susceptibility testing in patients with multiple eradication failures
Scientific Title:Acronym
Efficacy of Helicobacter pylori eradication regimen based on antibiotic susceptibility testing
Region
| Japan |
Condition
Condition
Patients with multiple eradication failures
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of antibiotic susceptibility testing based Helicobacter eradication therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of Hp eradication
Key secondary outcomes
Eradication rate of different regimen
Frequency of adverse effects
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
Third line eradication therapy with esomeprazole, amoxicillin, and sitafloxacin
Rescue therapy based on antibiotic susceptibility testing
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
1. Patients with past history of peptic ulcer, gastric MALT lymphoma, and early gastric cancer treated by endoscopic resection
2. Patients positive for H. pylori infection
3. Patients with two eradication failures by clarithromycin- and metronidazole-based regimen
Key exclusion criteria
1. Pregnancy
2. Lactation
3. Past history of allergy for the drugs used in this study.
4. Severe other organ dysfunction
5. Patients who are disqualified for the study by their physicians
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Hirata |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
hiratay-int@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Hirata |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(33070)
Homepage URL
hiratay-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, The University of Tokyo
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
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
| 2012 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1016/j.ijid.2016.08.019
Number of participants that the trial has enrolled
Results
All 30 patients completed the study. Eradication was successful in 25 patients and the eradication rate was 83% in the intention-to-treat and per-protocol analyses. No specific or significant adverse events were recorded in the 30 patients. Patient characteristics such as gender, body mass index, and pepsinogen I/II ratio did not differ between patients who were successfully treated and those who were not successfully treated.
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
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 16 | Day |
Last modified on
| 2016 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
