UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect of Rebamipide for the Patients with Reflux Esophagitis and Gastritis
Title of the study (Brief title)	Effect of Rebamipide
Region	Asia(except Japan)

Condition
Condition	Phase IV, multi-center, randomized, open-labeled, comparison study
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of rebamipide by investigating its symptomatic response in patients with reflux esophagitis and gastritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of a total symptom score after four-week administration of esomeprazole and rebamipide
Key secondary outcomes	The mean decrease in the total symptom score at 4 weeks since trial medicine, the change from baseline of reflux symptoms (heartburn and regurgitation), the proportion of patients with at least a 50% decrease in the symptoms score compared with their baseline score, and the proportion of patients reporting complete improvement of symptoms

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention group is treated by rebamipide and esomeprazole
Interventions/Control_2	Control group is treated by esomeprazole
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Adults aged over 20 years and less 70 years 2) Patients diagnosed as reflux esophagitis through esophagogastroduodenoscopy 3) Patients signing the informed consent document of this clinical study
Key exclusion criteria	1) Pregnant or lactating women, child bearing women not using a proper contraception 2) Patients with history of gastrointestinal surgery 3) Patients with gastric ulcer or duodenal ulcer 4) Patients with significant impairment in the heart, the lung, the blood or the endocrine system 5) Patients with psychiatric disorders or alcohol or drug addiction 6) Patients who are considered to be unsuitable by investigator(s) because of other reason
Target sample size	492

Research contact person
Name of lead principal investigator	Soo Heon Park
Organization	The Catholic University of Korea College of Medicine, Seoul, Korea.
Division name	Department of Internal Medicine
Address	62, Yeouido-dong, Yeongdeungpo-gu, Seoul, Korea
TEL	82-2-3779-1163
Email	psheon5132@naver.com

Public contact
Name of contact person	Su Jin Hong
Organization	Soonchunhyang University College of Medicine, Seoul, Korea
Division name	Department of Internal Medicine
Address	1174 Jung-dong Wonmi-gu, Bucheon, Korea
TEL	82-32-621-5087
Homepage URL
Email	sjhong@schmc.ac.kr

Sponsor
Institute	Korean College of Helicobacter and Upper Gastrointestinal Research
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	NO
Organization
Division
Category of Funding Organization	Self funding
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

Yeouido St. Mary's hospital (Seoul, Korea), Soonchunhyang University Bucheon Hospital(Bucheon, Korea), Chung-ang University Medical Center(Seoul, Korea), Seoul National University Bundang Hospital(Seongnam), Samsung Medical Center(Seoul, Korea), Inje University Seoul Paik Hospital(Seoul, Korea), Korea University Ansan Hospital(Ansan, Korea), Severance Hospital(Seoul, Korea), Hanyang University Hospital(Seoul, Korea), Kyung Hee University Hospital(Seoul, Korea), Hallym University Kangdong Sacred Heart Hospital(Seoul, Korea), Ruijin Hospital(China), 1st Affiliated Hospital of Anhui Meical University (China), 2nd Affiliated Hospital of Wenzhou Medical University (China), Tianjin General Hospital(China), Eastern Hospital (China), Siriraj Hospital of Mahidol University (Thailand), Cardinal Santos Medical Center (The Philippines)

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 15 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2014 Year 04 Month 20 Day
Date of closure to data entry	2014 Year 04 Month 25 Day
Date trial data considered complete	2014 Year 05 Month 10 Day
Date analysis concluded	2014 Year 05 Month 15 Day

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

Management information
Registered date	2011 Year 05 Month 15 Day
Last modified on	2016 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006621