UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000958 |
|---|---|
| Receipt number | R000001104 |
| Scientific Title | Randomized Contorolled Trial of efficacy of mosapride plus omeprazole versus omeprazole alone in therapy of gastroesophageal reflux disease |
| Date of disclosure of the study information | 2007/12/27 |
| Last modified on | 2010/12/28 14:30:10 |
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Basic information
Public title
Randomized Contorolled Trial of efficacy of mosapride plus omeprazole versus omeprazole alone in therapy of gastroesophageal reflux disease
Acronym
Tokyo university Omeprazole versus Gasmotin (R) (mosapride) plus Omeprazole study
Scientific Title
Randomized Contorolled Trial of efficacy of mosapride plus omeprazole versus omeprazole alone in therapy of gastroesophageal reflux disease
Scientific Title:Acronym
Tokyo university Omeprazole versus Gasmotin (R) (mosapride) plus Omeprazole study
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare the efficacy for the therapy of gastroesophageal reflux disease of omeprazole alone with a combination of omeprazole and mosapride.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoint is
improvement in the FSSG(Frequency Scale for the Symptoms of GERD).The FSSG was performed before the study.After 4 weeks of therapy with either regimen, FSSG was performed again.The levels of the improvement of the GERD symptom are compared in omeprazole and omeprazole plus mosapride .
Key secondary outcomes
1.GSRS score after 4 weeks
2.FSSG score stratified by nonerosive GERD and erosive GERD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
omeprazole 10mg qd after breakfast for 4 weeks
Interventions/Control_2
omeprazole 10mg qd after breakfast plus mosapride 5mg tid for 4 weeks
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who fills everything the following
1)Patient with GERD(erosive and nonerosive)
2)Patient of 20 years or more
3)Patient who gives written informed consent
4)Outpatient and in-patient
Key exclusion criteria
The patient who collides with either the following assumes that it doesn't put it in to the examination
1)Patient with gastric or duodenal ulcer
2)Patient with malignant neoplasm, diabetes or thyroid disease
3)Patient who has severe liver disease.(AST(GOT) or ALT(GPT) is 100 U or more )
4)Patient who has severe renal dysfunction(BUN 25mg/dL or more or serum creatinine 2.0 mg/dL or more)
5)Patient who has the pasts of digestive tract operations other than appendectomy
6)Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks
7)Alcohol or drug abuse
8)Pregnant females and lactating women
9)Patient whom examination doctor judged improper as testee
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamaji |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
03-3815-5411(33070)
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, The University of Tokyo Hospital
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
| 2007 | Year | 12 | Month | 27 | 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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 26 | Day |
Last modified on
| 2010 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001104
