UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021787 |
|---|---|
| Receipt number | R000025125 |
| Scientific Title | Examination of the acotiamide effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosive- gastroesophageal reflux disease with the functional dyspepsia symptom. -A randomized, double-blind,placebo-controlled,crossover studt- |
| Date of disclosure of the study information | 2016/04/06 |
| Last modified on | 2019/04/08 09:23:43 |
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Basic information
Public title
Examination of the acotiamide effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosive- gastroesophageal reflux disease with the functional dyspepsia symptom. -A randomized, double-blind,placebo-controlled,crossover studt-
Acronym
Examination of the acotiamide effect on reflux symptom in patients with PPI resistant NERD with the functional dyspepsia symptom
Scientific Title
Examination of the acotiamide effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosive- gastroesophageal reflux disease with the functional dyspepsia symptom. -A randomized, double-blind,placebo-controlled,crossover studt-
Scientific Title:Acronym
Examination of the acotiamide effect on reflux symptom in patients with PPI resistant NERD with the functional dyspepsia symptom
Region
| Japan |
Condition
Condition
Effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosion-related gastroesophageal reflux disease with the functional dyspepsia symptom
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We weigh a symptom and the quality of life improvement effect of acotiamide on PPI-resistant NERD patients with the functional dyspepsia symptom against placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Four weeks later, we weigh it against GERD symptom (FSSG) in QOL(SF-36,GSRS) if before internal use.
Key secondary outcomes
Of FD symptom (FD score of FD interview ,FSSG) and the esophagus clearance weigh.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
It is the placebo group from the Ako thiamide group
Interventions/Control_2
It is the Ako thiamide group from the placebo group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The PPI-resistant NERD patients with the FD symptom
Key exclusion criteria
Serious complications
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Funaki |
Organization
Aichi Medical University
Division name
Division of Gastroenterology
Zip code
Address
1-1Yazakokarimata,Nagakute,Aichi,Japan
TEL
0561-62-3311
momomaru@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Funaki |
Organization
Aichi Medical University
Division name
Division of Gastroenterology
Zip code
Address
1-1Yazakokarimata,Nagakute,Aichi,Japan
TEL
0561-62-3311
Homepage URL
momomaru@aichi-med-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology Department of Internal Medicine Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology Department of Internal Medicine Aichi Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 04 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 05 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025125
