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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001611 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Renal disease | |
Classification by specialty |
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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 |
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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. |
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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.
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
Institutions | |
Institutions |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 | |
Registered date | File name |
Research case data | |
Registered date | File name |