UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013582 |
|---|---|
| Receipt number | R000015865 |
| Scientific Title | Study of the effect of packaged drug sets for eradication of Helicobacter pylori on the improvement of adherence. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/01/24 17:43:18 |
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Basic information
Public title
Study of the effect of packaged drug sets for eradication of Helicobacter pylori
on the improvement of adherence.
Acronym
Study of the effect of packaged drug sets for eradication of Helicobacter pylori
on the improvement of adherence.
Scientific Title
Study of the effect of packaged drug sets for eradication of Helicobacter pylori
on the improvement of adherence.
Scientific Title:Acronym
Study of the effect of packaged drug sets for eradication of Helicobacter pylori
on the improvement of adherence.
Region
| Japan |
Condition
Condition
atrophic gastritis, gastric ulcer, duodenal ulcer, MALToma, ITP, and early gastric cancer (post endoscopic therapy)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate eradication rate, compliance, and comprehension of adverese effects in both packaged and non-packaged drug sets groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compliance and comprehension of adverse effects
Key secondary outcomes
success rate of eradication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eradication therapy for 7days using packaged drug sets
Interventions/Control_2
eradication therapy for 7days using non packaged drug sets
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
patients over 20 years old who have any one of atrophic gastritis, gastric ulcer, duodenal ulcer, post endoscopit therapeutic gastric cancer, ITP, and gastric MALToma
Key exclusion criteria
patients who have any allergy to drugs
patients who have untreated gastric cancer
pregnant woman
nursing woman
patient who underwent upper gastrointestinal surgery
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Aimi |
Organization
Shimane University Faculty of medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1, Enya-cho, Izumo-shi
TEL
0853-20-2190
aimi@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahito Aimi |
Organization
Shimane University Faculty of medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1, Enya-cho, Izumo-shi
TEL
0853-23-2111
Homepage URL
aimi@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of medicine
Department of Gastroenterology and Hepatology
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
| 2014 | Year | 04 | Month | 01 | 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
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 26 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015865
| 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 |
