UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000927 |
|---|---|
| Receipt number | R000000860 |
| Scientific Title | Double-blind placebo-controlled comparative study for the efficacy of treatment on the patient with NERD between omeprasole versus omeprasole plus mosapride citrate |
| Date of disclosure of the study information | 2007/12/10 |
| Last modified on | 2010/01/22 10:49:23 |
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Basic information
Public title
Double-blind placebo-controlled comparative study for the efficacy of treatment on the patient with NERD between omeprasole versus omeprasole plus mosapride citrate
Acronym
Treatment of NERD Study
Scientific Title
Double-blind placebo-controlled comparative study for the efficacy of treatment on the patient with NERD between omeprasole versus omeprasole plus mosapride citrate
Scientific Title:Acronym
Treatment of NERD Study
Region
| Japan |
Condition
Condition
NERD (non-erosive reflux disease)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy between omeprazole and omeprazole pulse mosapride citrate on patients with non-erosive reflux disease (NERD) by double-blind placebo control method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of the patients with none or minimal symptoms
Key secondary outcomes
1. Mean of VAS score
2. GSRS Score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ome
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
non
Key exclusion criteria
non
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine Division of Upper Gastroenterology
Zip code
Address
1-1, Mukogawa-cho Nishinomiya, Hyogo
TEL
0798-45-6665
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine Division of Upper Gastroenterology
Zip code
Address
1-1, Mukogawa-cho Nishinomiya, Hyogo
TEL
0798-45-6665
Homepage URL
miwa-sec@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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 | 10 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 03 | Day |
Last modified on
| 2010 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000860
