UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034305 |
|---|---|
| Receipt number | R000039096 |
| Scientific Title | Effective use of Drinking-Ultrasonography for the diagnosis of Helicobacter pylori-associated dyspepsia |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/09/27 14:55:33 |
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Basic information
Public title
Effective use of Drinking-Ultrasonography for the diagnosis of Helicobacter pylori-associated dyspepsia
Acronym
Drinking-Ultrasonography for Helicobacter pylori-associated dyspepsia
Scientific Title
Effective use of Drinking-Ultrasonography for the diagnosis of Helicobacter pylori-associated dyspepsia
Scientific Title:Acronym
Drinking-Ultrasonography for Helicobacter pylori-associated dyspepsia
Region
| Japan |
Condition
Condition
Helicobacter pylori-associated dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether Drinking-Ultrasonography Test is effective for the early diagnose of Helicobacter pylori-associated dyspepsia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calculate the correct diagnosis rate of Helicobacter pylori-associated dyspepsia with sensory hypersensitivity by Drinking-Ultrasonography Test at 2 months, 6 months to 1 year after eradication
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Persons whose age is 20 years or older at the time of acquiring consent
2)Helicobacter pylori infected patients
3)The patients who will perform eradication therapy
4)Persons who have recorded GSRS (Gastrointestinal Symptom Rating Scale) and GOS (Global Overall Severity) that evaluate abdominal symptoms before eradication
5)The patients who will perform upper gastointestinal endoscopy before eradication
6)The patients who will perform Drinking-Ultrasonograhy Tet before eradication
7)Patients from whom written informed consent is obtained.
Key exclusion criteria
1)The patients who have allergic to eradication drugs
2)The patients with organic disease in the stomach
3)Patients who are judged as being inappropriate for this study by their medical doctor
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-716-1161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Momoko Tsuda |
Organization
Hokkaido University Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
momoko0221tsuda@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory prospective study to conduct Drinking-Ultrasonography Test before and after eradication
Management information
Registered date
| 2018 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039096
