UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012000 |
|---|---|
| Receipt number | R000014022 |
| Scientific Title | Investigation of the efficacy of Esomeprazole for 8 weeks to the proton pomp inhibitor (PPI)-resistant gastro-esophageal reflux disease (GERD) patients |
| Date of disclosure of the study information | 2013/10/15 |
| Last modified on | 2015/11/09 11:21:51 |
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Basic information
Public title
Investigation of the efficacy of Esomeprazole for 8 weeks to the proton pomp inhibitor (PPI)-resistant gastro-esophageal reflux disease (GERD) patients
Acronym
Investigation of the efficacy of Esomeprazole for 8 weeks to the gastro-esophageal reflux disease (GERD) patients
Scientific Title
Investigation of the efficacy of Esomeprazole for 8 weeks to the proton pomp inhibitor (PPI)-resistant gastro-esophageal reflux disease (GERD) patients
Scientific Title:Acronym
Investigation of the efficacy of Esomeprazole for 8 weeks to the gastro-esophageal reflux disease (GERD) patients
Region
| Japan |
Condition
Condition
Gastroesophageal
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Esomeprazole for 8 weeks to improve QOL of the PPI-resistant GERD patients in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of QOL score using QOLRAD-J questionnaire
Improvement of symptom score using GERDQ questionnaire
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PPI-resistant GERD patients will be separated two groups;1.changing to Esomeprazole.
Interventions/Control_2
PPI-resistant GERD patients will be separated two groups;2.adding mosapride to Rabeprazole,Lansoprazole.
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.Over 20 years GERD patients prescribed PPI (Rabeprazole 10mg or Lansoprazole 15mg) for more than 8 weeks
2.The patients having symptom of GERD
Key exclusion criteria
1. Severe liver function failure (AST or ALT >100IU/l)
2. Severe heart failure
3. Patients with malignant disease
4. Patients with HIV positive or AIDS
5. Patients received vagolysis
6. Patients received surgery with upper gastrointestinal tract
7. Patients prescribed prohibited concomitant drugs
8. Patients having allergy for Esomeprazole or the similar drugs
9. Patients having difficulty of writing questionnaire sheets
10. Patients who are pregnant
11. Nursing wemen
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Toyokawa |
Organization
NationalOrganizationHospital Fukuyama medical center
Division name
Department of Gastroenterology
Zip code
Address
4-14-17 Okinogami-cho,Fukuyama-city,Hiroshima
TEL
084-922-0001
toyotatu@kmail.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Toyokawa |
Organization
NationalOrganizationHospital Fukuyama medical center
Division name
Department of Gastroenterology
Zip code
Address
4-14-17 Okinogami-cho,Fukuyama-city,Hiroshima
TEL
084-922-0001
Homepage URL
toyotatu@kmail.plala.or.jp
Sponsor or person
Institute
NationalOrganizationHospital Fukuyama medical center
Institute
Department
Personal name
Funding Source
Organization
NationalOrganizationHospital Fukuyama medical center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
国立病院機構 福山医療センター(広島県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 15 | 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
| 2013 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2015 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014022
