UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009124 |
|---|---|
| Receipt number | R000010297 |
| Scientific Title | Effect of Esomeprazole on quality of life in hemodialysis patients with Gastroesophageal reflux disease (GERD) symptom |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2015/06/29 09:04:26 |
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Basic information
Public title
Effect of Esomeprazole on quality of life in hemodialysis patients with Gastroesophageal reflux disease (GERD) symptom
Acronym
Effect of Esomeprazole on QOL in hemodialysis patients with GERD
Scientific Title
Effect of Esomeprazole on quality of life in hemodialysis patients with Gastroesophageal reflux disease (GERD) symptom
Scientific Title:Acronym
Effect of Esomeprazole on QOL in hemodialysis patients with GERD
Region
| Japan |
Condition
Condition
Hemodialysis outpatients with GERD symptom according to the GOS questionnaire
Classification by specialty
| Medicine in general | Gastroenterology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the proportion of GERD symptom in hemodialysis outpatients and the effect of 20mg/day Esomeprazole for 4 weeks on disease-specific QOL in hemodialysis outpatients with GERD symptom
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of QOL according to the QOLRAD-J questionnaire after the administration of 20mg/day Esomeprazole for 4 weeks
Key secondary outcomes
1) The proportion of upper abdominal symptom according to the GOS questionnaire in hemodialysis patients
2) The change of GERD symptom according to the GOS questionnaire after the administration of 20mg/day Esomeprazole for 4 weeks
3) The correlation between the scores of GOS and QOLRAD-J questionnaires before and 4 weeks after the intervention
4) The decrease on QOL in hemodialysis patients with GERD symptom compared with those without GERD symptom before the intervention
5) The rate of the detrimental events caused by the intervention drug
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 20mg/day Esomeprazole for 4 weeks
Interventions/Control_2
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
1) Outpatients with thrice-per-week hemodialysis in which it takes more than 3 hours each
2) Patients with GERD symptom according to the GOS questionnaire
3) Patients with the informed consent to this study
Key exclusion criteria
1) Patients with severe hepatic dysfunction (showing more than 100 IU/L of AST or ALT)
2) Patients with severe cardiac dysfunction
3) Patients receiving treatment for a malignant neoplasm
4) Patinets with HIV infection or receiving treatment for AIDS
5) Patients with the past history of vagotomy
6) Patients with the past history of the resection of upper digestive tract
7) Patients taking a contraindication drug for coadministration of Esomeprazole
8) Patients with current or past hypersensitivity to Esomeprazole or the similar drugs such as proton pump inhibitors (PPI)
9) Patients for whom it is difficult to fill out the questionnaires by themselves
10) Female in current or expected pregnancy
11) Female in breast-feeding
12) Patients judged as unsuitable for participating in this study by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Komai |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
komai@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamehachi Namikoshi |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Homepage URL
tnamikoshi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2012 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s10157-015-1130-2
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
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 09 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 16 | Day |
Last modified on
| 2015 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010297
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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