UMIN-CTR Clinical Trial

Basic information
Public title	The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study-
Acronym	The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study-
Scientific Title	The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study-
Scientific Title:Acronym	The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study-
Region	Japan

Condition
Condition	Renal disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study-
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The current study attempted to compare the efficacy of rabeprazole with rebamipide after 12-week treatment in renal disease patients taking a oral steroid with or without H. pylori infections.
Key secondary outcomes	Gastrointestinal symptom.(Gastrointesitinal Symptom Rating Scale) upper gastrointestinal endoscopy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	This randomized, single-center study was conducted according to the Declaration of Helsinki. We asked the patients about the following 6 symptoms: early satiety; belching; daytime heartburn; nocturnal heartburn; epigastric pain; or discomfort. All of dyspepsia symptoms were rated by patients on a seven-point categorical scale (0; none, 1: slight, 2: mild, 3: moderate, 4: severe, 5: very severe, 6: worst possible. When patients have a score less than 3 points for 6 symptoms and patients do not have peptic ulcer by endoscopic finding, the participants were randomly divided into three treatment arms in each of the groups. Patients was randomly assigned to receive 100 mg rebamipide 3 times per day after each meal, or 10 mg rabeprazole once a day after breakfast, no taking a drug(Placebo) during 12 months.
Interventions/Control_2	When patients have a score greater than 4 points for at least one of the 6 symptoms, patients was randomly assigned to receive 100 mg rebamipide 3 times per day after each meal, or 10 mg rabeprazole once a day after breakfast during 12 months.
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	renal disease patients with taking a oral steroid at the graduate School of Medicine Science, Kumamoto University.
Key exclusion criteria	Patients were excluded if patients had been malignant disease, previous upper abdominal surgery, neuropsychiatric disorder, organic brain damage, hepato-renal disorder, cardiopulmonary disorder, symptoms suggesting or were pregnant.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yutaka Sasaki
Organization	Graduate School of Medicine Science, Kumamoto University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN
TEL	096-373-5150(+81-96-373-5150)
Email	sakurai@s3.kcn-tv.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Kouichi Sakurai
Organization	Graduate School of Medicine Science, Kumamoto University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN
TEL	096-373-5150(+81-96-373-5150)
Homepage URL
Email	sakurai@s3.kcn-tv.ne.jp

Sponsor
Institute	Graduate School of Medicine Science, Kumamoto University
Institute
Department

Funding Source
Organization	Graduate School of Medicine Science, Kumamoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
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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	2009 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry	2011 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded	2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2009 Year 01 Month 01 Day
Last modified on	2017 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001933

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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