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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036265
Receipt No. R000041308
Scientific Title A study of factors which predicts the therapeutic effect of acotiamide on abdominal symptoms in patients with Functional dyspepsia.
Date of disclosure of the study information 2019/03/22
Last modified on 2019/03/20

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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