UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011744 |
|---|---|
| Receipt number | R000013732 |
| Scientific Title | Diagnosis of Helicobacter pylori associated gastritis by serum pepsinogen levels |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2016/12/27 08:22:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Diagnosis of Helicobacter pylori associated gastritis by serum pepsinogen levels
Acronym
Pepsinogen and H.pylori gastritis
Scientific Title
Diagnosis of Helicobacter pylori associated gastritis by serum pepsinogen levels
Scientific Title:Acronym
Pepsinogen and H.pylori gastritis
Region
| Japan |
Condition
Condition
Helicobacter pylori associated gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the appropriate cutoff value of the serum pepsinogen levels in the diagnosis of H.pylori gastritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Comparison of the serum pepsinogen levels by presence or absence of H.pylori infection
Key secondary outcomes
Investigation of the changes of the serum pepsinogen levels by success of H.pylori eradication according to endoscopic atrophy and histologic gastritis before the eradication
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
Endoscopic subjects who want to receive a Helicobacter pylori infection test and to take eradication treatment if its result is positive.
Patients who give a written informed consent
Key exclusion criteria
Past history of allergy for the drugs used in this study.
Past history of taking eradication therapy.
Past history of gastrectomy.
Gastric cancer patients,
Pregnancy or lactation,
Severe renal dysfunction ,Blood disease,
Infectious Mononucleosis
Patients who are disqualified for the study by their physicians
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
N14,W5,Kita-ku,Sapporo,Hokkaido
TEL
011-716-1161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Mabe |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
N14,W5,Kita-ku,Sapporo,Hokkaido
TEL
011-716-1161
Homepage URL
kmabe@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Gast Study Group
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
| 2013 | Year | 09 | Month | 13 | 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 | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013732
