UMIN-CTR Clinical Trial

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
Last 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
Email	momomaru@aichi-med-u.ac.jp

Public contact
1st 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
Email	momomaru@aichi-med-u.ac.jp

Sponsor
Institute	Division of Gastroenterology Department of Internal Medicine Aichi Medical University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025125