UMIN-CTR Clinical Trial

Basic information
Public title	A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.
Acronym	A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.
Scientific Title	A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.
Scientific Title:Acronym	A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.
Region	Japan

Condition
Condition	Functional dyspepsia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A multicenter study aimed at extracting factors associated with the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of effects on GOS and OTE questionnaires at 2 and 4 weeks of medication
Key secondary outcomes	Serum helicobacter pylori antibody Serum pepsinogen levels Adverse events, medication status, presence of constipation, duration of illness, symptoms, endoscopic findings

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Adults who have any upper gastrointestinal symptoms for more than one month, have a medical institution visit and no organic abnormalities have been pointed out by examinations including an endoscope, and are considered as functional upper gastrointestinal symptoms case. 2) Age at registration: 20 to 85 years, no gender (at registration) 3) Those who gave a written and verbal explanation and obtained written consent for participation in research freely. 4) The patient's general condition is good (performance status 0)
Key exclusion criteria	1) Those that have been prescribed acid secretion inhibitors and digestive tract movement improving agents within one month. 2) Person who are taking non-steroidal analgesics,steroids, immunosuppressants 3) Endoscopic examination with organic abnormalities that cause symptoms such as erosive reflux esophagitis 4) There is no problem if heartburn and IBS symptoms accompany, but heartburn and IBS symptoms dominate 5) Person who is suspected of mental illness 6) Potentially pregnant, pregnant 7) Person who have serious systemic illness 8) Person who have a history of upper abdominal surgery for esophagus, stomach and duodenum (except for endoscopic treatment), or if you are planning 9) Person who have uncontrolled diabetes 10) Those who received H. pylori eradication treatment within 6 months 11) In addition, those who the research investigator or co-investigator judged as inappropriate for study participation
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Katsunori Middle name Last name iijima
Organization	Akita University Graduate School of Medicine
Division name	Department of Gastroenterology and Neurology
Zip code	0108543
Address	1-1-1 Hondo, Akita City, Akita, Japan
TEL	018-884-6104
Email	kiijima@med.akita-u.ac.jp

Public contact
1st name of contact person	1st name Reina Middle name Last name Ohba
Organization	Akita University Graduate School of Medicine
Division name	Department of Gastroenterology and Neurology
Zip code	0108543
Address	1-1-1 Hondo, Akita City, Akita, Japan
TEL	018-884-6104
Homepage URL
Email	reina@doc.med.akita-u.ac.jp

Sponsor
Institute	Akita University Graduate School of Medicine Department of Gastroenterology and Neurology
Institute
Department

Funding Source
Organization	Akita University Graduate School of Medicine Department of Gastroenterology and Neurology
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	Akita University Graduate School of Medicine
Address	1-1-1 Hondou, Akita City, Akita, Japan
Tel	0188846104
Email	reina@doc.med.akita-u.ac.jp

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	秋田大学病院（秋田県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 22 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	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 31 Day
Date of IRB	2017 Year 05 Month 31 Day
Anticipated trial start date	2017 Year 05 Month 31 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Under multi-center collaborative research by primary care physicians

Management information
Registered date	2019 Year 03 Month 20 Day
Last modified on	2019 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041308