UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of the association of low-dose aspirin and reflux esophagitis
Title of the study (Brief title)	The investigation of the association of low-dose aspirin and reflux esophagitis
Region	Japan

Condition
Condition	Reflux esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate whether low-dose aspirin is related to reflux esophagitis and to evaluate treatment response of proton pump inhibitor for reflux esophagitis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The risk odds ratio of the low-dose aspirin for the reflux esophagitis onset
Key secondary outcomes	The rate that reflux esophagitis improves by proton pump inhibitor administration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We let reflux esophagitis patients take esomeprazole 20mg/day for 8 weeks
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who diagnosed as reflux esophagitis, Los Angeles classification, grade A, B, C, or D, by esophagogastroduodenoscopy
Key exclusion criteria	1. Patients with active gastric ulcer or duodenal ulcer. 2. Patients with hypersensitivity to esomeprazole. 3. Patients in the administration of atazanavir sulfate or a Rirupibirin hydrochloride. 4. Patients with chronic alcoholism or drug dependence. 5. Patients with warning symptoms, such as vomitting, or sudden weight loss. 6. The patient who has difficulty in participation in this examination by the mergers such as a serious liver disease, renal disease, or heart trouble. 7. Pregnant women, nursing girls or the women who may be pregnant. 8. Patients who judged unsuitable for research participation.
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuhiro Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Address	1-1, Idaigaoka, Hasama, Yufu, Oita
TEL	097-586-6193
Email	mizkaz0809@oita-u.ac.jp

Public contact
Name of contact person	Kazuhiro Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Address	1-1, Idaigaoka, Hasama, Yufu, Oita
TEL	097-586-6193
Homepage URL
Email	mizkaz0809@oita-u.ac.jp

Sponsor
Institute	Oita university, department of Gastroenterology
Institute
Department

Funding Source
Organization	Non-profit Organization for Promotion of Gastrointestinal Disease Treatment Research
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 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 19 Day
Anticipated trial start date	2014 Year 04 Month 01 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

Management information
Registered date	2014 Year 07 Month 13 Day
Last modified on	2017 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016909