UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018164 |
|---|---|
| Receipt number | R000021043 |
| Scientific Title | Comparison of non-bismuth concomitant and standard triple therapies as a first-line treatment option for Helicobacter pylori in Japan |
| Date of disclosure of the study information | 2015/07/03 |
| Last modified on | 2020/01/08 16:42:49 |
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Basic information
Public title
Comparison of non-bismuth concomitant and standard triple therapies as a first-line treatment option for Helicobacter pylori in Japan
Acronym
Concomitant therapies for Helicobacter pylori first line eradication
Scientific Title
Comparison of non-bismuth concomitant and standard triple therapies as a first-line treatment option for Helicobacter pylori in Japan
Scientific Title:Acronym
Concomitant therapies for Helicobacter pylori first line eradication
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative analysis of efficacy and safety in eradication therapy as 1st line, PPI+AMPC+CAM+MNZ versus
PPI+AMPC+CAM
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the eradication rate of the two regimens, PPI+AMPC +CAM+MNZ versus PPI+AMPC+CAM for first line
Key secondary outcomes
Comparison of the safety of the two regimens, PPI+AMPC +CAM+MNZ versus PPI+AMPC+CAM for first line
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PPI+AMPC +CAM+MNZ
Interventions/Control_2
PPI+AMPC+CAM
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with H.pylori infection who want to take eradication therapy. Patients who give a written informed consent.
Key exclusion criteria
Patients were excluded from the study if they were younger than 20 years or older than 80 years, were allergic to the drugs used in this therapy. Patients who are disqualified for the study by physicians.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Takagi |
Organization
Tokai University School of Medicine
Division name
General Internal Medicine
Zip code
Address
143 Shimokasuya Isehara, Kanagawa, 259-1193 Japan
TEL
0463-93-1121
takagia@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayoshi Suzuki |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology & Hepatology
Zip code
Address
143 Shimokasuya Isehara Kanagawa Japan 259-1193
TEL
0463-93-1121
Homepage URL
takayosh@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University
Hamamatsu University School of Medicine
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
東海大学付属病院/Tokai University School of Medicine（神奈川県）
東京医科大学/ Tokyo Medical University（東京都）
浜松医科大学/ Hamamatsu University School of Medicine（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 03 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021043
