UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036265 |
|---|---|
| Receipt number | 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 16:37:59 |
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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
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
reina@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Department of Gastroenterology and Neurology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041308
