UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of Helicobacter pylori associated gastritis by serum pepsinogen levels
Title of the study (Brief title)	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	Mototsugu Kato
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	N14,W5,Kita-ku,Sapporo,Hokkaido
TEL	011-716-1161
Email	m-kato@med.hokudai.ac.jp

Public contact
Name of contact person	Katsuhiro Mabe
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	N14,W5,Kita-ku,Sapporo,Hokkaido
TEL	011-716-1161
Homepage URL
Email	kmabe@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013732