UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011676 |
|---|---|
| Receipt number | R000013653 |
| Scientific Title | Esomeprazole 20mg versus rabeprazole 10mg for the resolution of gastroesophageal reflux symptoms, Non-Inferiority randomized open-label cross over comparative study |
| Date of disclosure of the study information | 2013/09/08 |
| Last modified on | 2015/09/07 13:51:48 |
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Basic information
Public title
Esomeprazole 20mg versus rabeprazole 10mg for the resolution of gastroesophageal reflux symptoms, Non-Inferiority randomized open-label cross over comparative study
Acronym
Esomeprazole 20mg versus rabeprazole 10mg for the resolution of gastroesophageal reflux symptoms, Non-Inferiority randomized open-label cross over comparative study
Scientific Title
Esomeprazole 20mg versus rabeprazole 10mg for the resolution of gastroesophageal reflux symptoms, Non-Inferiority randomized open-label cross over comparative study
Scientific Title:Acronym
Esomeprazole 20mg versus rabeprazole 10mg for the resolution of gastroesophageal reflux symptoms, Non-Inferiority randomized open-label cross over comparative study
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the resolution of symptoms with esomeprazole 20mg/day or rabeprazole 10mg/day in gastroesophageal reflux disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resolution Rate of gastroesophageal reflux disease symptom with each treatment after 2 weeks
Key secondary outcomes
Improvement rate of gastroesophageal reflux disease symptom with each treatment after 2 weeks
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Esomeprazole20mg/day1,14days
Interventions/Control_2
Rabeprazole10mg/day,14days
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)Patients who have freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study.
(2)Patients of either sex who are at least 20 years of age.
(3)Patients whose are taking medication of Proton pump inhibitors or Histamine 2 Receptor Antagonists already can be washout of these medications for one week.
Key exclusion criteria
(1)Patients with a history of gastrointestinal resection or vagotomy
(2)Patients whose participation in this study would be contraindicated due to complications such as serious hepatic disease, renal disease, bloody disease, cardiac disease or malignant disease.
(3)Women who are pregnant or who may possibly be pregnant, and lactating mothers
(4)Other patients whom the investigator considers unsuitable for admission to the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyasu chibai |
Organization
Heiwadai clinic
Division name
Surgery
Zip code
Address
4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan
TEL
03-5922-1241
bk2m-cbi@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyasu chibai |
Organization
Heiwadai clinic
Division name
Surgery
Zip code
Address
4-26-8,Heiwadai,Nerima-ku,Tokyo,Japan
TEL
03-5922-1241
Homepage URL
bk2m-cbi@asahi-net.or.jp
Sponsor or person
Institute
Heiwadai clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 07 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013653
