UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on relapse of the symptom comparing 2 weeks and 8 weeks of treatment period in GERD patients using the newly established GerdQ questionnaires
Title of the study (Brief title)	GERD treatment period study
Region	Japan

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

Objectives
Narrative objectives1	To compare the relapse of GER symptoms in relation with the length of the treatment in the patients with reflux esophagitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	length of the GER symptom free periods after the treatment
Key secondary outcomes	1) factors affecting the relapse of GERD 2) difference of GER symptoms between before and after the 2 week treatment and the rates of the disappearance of GER symptoms 3) the severity of GER symptoms in case of the relapse

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	no additional treatment
Interventions/Control_2	Additional treatment of esomeprazole for 6 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	LA grade A or B diagnosed by esophagoscopy within 6 months Having GER symptoms Disappearance of GER symptoms after the treatment by esomeprazole (20 mg/day for 2 weeks) by GerdQ questionnaire
Key exclusion criteria	Patiets with the history of gastric surgeries Patients with alarm symptoms such as vomiting, GI bleeding, rapid body weight loss Patients of alcohol or drug dependence Patients with severe endocrine problems Patients with severe injuries of heart, liver, kidney or bone marrow functions Patients with allergy against the test drugs Patients with pregnancy, possible pregnancy or breast feeding, or hope of pregnancy during the test period Patients whom the doctor decide as not proper for the study
Target sample size	80

Research contact person
Name of lead principal investigator	Masashi Matsushima
Organization	Tokai University Tokyo Hospital
Division name	Internal Medicine (Gastroenterology)
Address	1-2-5 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
TEL	03-3370-2321
Email

Public contact
Name of contact person	Masashi Matsushima
Organization	Tokai University Tokyo Hospital
Division name	Internal Medicine (Gastroenterology)
Address	1-2-5 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
TEL	03-3370-2321
Homepage URL
Email

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Showa University Hospital
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	東海大学東京病院(東京都) Tokai University Tokyo Hospital 東海大学医学部付属病院(神奈川県) Tokai University Hospital 昭和大学病院（東京都）Showa University Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 06 Month 11 Day
Anticipated trial start date	2012 Year 07 Month 30 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 06 Month 30 Day
Date trial data considered complete	2014 Year 06 Month 30 Day
Date analysis concluded	2014 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 27 Day
Last modified on	2016 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010051