UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective observational study about the effect of gastric acid suppressive drug on gastric mucosa
Title of the study (Brief title)	Effect of gastric acid suppressive drug on gastric mucosa
Region	Japan

Condition
Condition	gastritis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of gastric acid suppressive drug on gastric mucosa.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Histological change of gastric mucosa in the antrum and corpus.
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	966 patients who performed upper GI endoscopy with gastric biopsy in order to investigate gastritis and H. pylori infection between Jan 1, 2010 and March 31, 2013 in Kawasaki Medical School.
Key exclusion criteria	None
Target sample size	966

Research contact person
Name of lead principal investigator	Tomoari Kamada
Organization	Kawasaki Medical School
Division name	Department of Internal Medicine, Division of Gastroenterology
Address	577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL	086-462-1111
Email	tkamada@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Tomoari Kamada
Organization	Kawasaki Medical School
Division name	Department of Internal Medicine, Division of Gastroenterology
Address	577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL	086-462-1111
Homepage URL
Email	tkamada@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Astellas Pharma Inc
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	2014 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 14 Day
Last follow-up date	2016 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	2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	None

Management information
Registered date	2014 Year 06 Month 12 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016595