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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009124
Receipt No. 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

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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
Email 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
Email tnamikoshi@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010297

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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