UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001611 |
|---|---|
| Receipt number | R000001933 |
| Scientific Title | The prevention effect in renal disease patients taking a oral steroid with the rebamipide or the rabeprazole- a randomized control study- |
| Date of disclosure of the study information | 2009/01/05 |
| Last modified on | 2017/06/08 20:29:31 |
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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)
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
sakurai@s3.kcn-tv.ne.jp
Sponsor or person
Institute
Graduate School of Medicine Science, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001933
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
