UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026364 |
|---|---|
| Receipt number | R000030293 |
| Scientific Title | The effect of acotiamide on gastroesophageal reflux events and reflux symptoms in patients with refractory gastroesophageal reflux disease (GERD) who are taking acid suppressive drugs |
| Date of disclosure of the study information | 2017/03/03 |
| Last modified on | 2019/02/04 15:44:08 |
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Basic information
Public title
The effect of acotiamide on gastroesophageal reflux events and reflux symptoms in patients with refractory gastroesophageal reflux disease (GERD) who are taking acid suppressive drugs
Acronym
The effect of acotiamide for refractory GERD
Scientific Title
The effect of acotiamide on gastroesophageal reflux events and reflux symptoms in patients with refractory gastroesophageal reflux disease (GERD) who are taking acid suppressive drugs
Scientific Title:Acronym
The effect of acotiamide for refractory GERD
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of acotiamide for refractory GERD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
Subject's global assessment of overall treatment efficacy at 2 weeks
Key secondary outcomes
Patients rated of each symptoms at 2 weeks
Change of reflux pattern at 2 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
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
acotiamide 300mg 2 weeks
Interventions/Control_2
Placebo 2 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastric acid inhibitor refractory GERD
Key exclusion criteria
Patients with severe complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamashita |
Organization
Saiseikai Nakatsu Hospital
Division name
Gastroenterology
Zip code
Address
Shibata Kitaku Osaka
TEL
0603520333
onakaryoko0310@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamasita |
Organization
Saiseikai Nakatsu Hospital
Division name
Gastroenterology
Zip code
Address
Shibata Kitaku Osaka
TEL
0663520333
Homepage URL
onakaryoko0310@gmail.com
Sponsor or person
Institute
saiseikai nakatsu hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shimane Univercity
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
大阪府済生会中津病院（大阪府）
島根大学（島根県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://links.springernature.com/f/a/HhO_T4LtwsmzFQ0pcn0P-Q~~/AABE5gA~/RgRd2b7iP0QwaHR0cDovL3d3dy5zcH
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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
