UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011260 |
|---|---|
| Receipt number | R000013196 |
| Scientific Title | A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2014/01/24 18:56:57 |
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Basic information
Public title
A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Acronym
A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Scientific Title
A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Scientific Title:Acronym
A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease (GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of acotiamide on esophageal motor function and gastro-esophageal reflux in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of esophageal motor function and gastro-esophageal reflux after administration of acotiamide for one week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
acotiamide 3 times a day for 1 week-for 1 week- no administration for 1 week
Interventions/Control_2
no administration for 1 week- for 1 week- acotiamide 3 times a day for 1 week
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. healthy adults
2. subjects with written informed consent
Key exclusion criteria
1. subjects with a history of allergy for drugs
2. subjects with a history of allergy for anesthetic drug
3. subjects with a history of gastrectomy and/or vagotomy
4. subjects undergoing treatment with some disease
5. Others who are not eligible for participation judged by a doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501
TEL
0853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501
TEL
0853-20-2190
Homepage URL
ishimura@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
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 | 08 | Month | 01 | 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 | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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 | 07 | Month | 24 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013196
