UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015248 |
|---|---|
| Receipt number | R000017724 |
| Scientific Title | Effects of acotiamide on patients with esophageal motility disorders |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/06/19 20:20:36 |
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Basic information
Public title
Effects of acotiamide on patients with esophageal motility disorders
Acronym
Acotiamide and esophageal motility disorders
Scientific Title
Effects of acotiamide on patients with esophageal motility disorders
Scientific Title:Acronym
Acotiamide and esophageal motility disorders
Region
| Japan |
Condition
Condition
Functional dyspepsia with esophageal motility disorders
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study is to evaluate usefulness of acotiamide for patients with esophageal motility disorders based on symptoms and esophageal motility function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
symptoms based on F scale (frequency scale for the symptoms of GERD) and GSRS (gastrointestinal symptom rating scale)
Key secondary outcomes
Parameters of high resolution manometry (HRM) including DCI, IRP and LES pressure)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients older than 20 years old.
2. Patients with functional dyspepsia suffering from abdominal fullness, bloating, early satiation.
3. Patients who also have symptoms suspecting esophageal motility disorders, which is confirmed by High resolution manometry.
4. Patients where written informed consent is obtained.
Key exclusion criteria
1. Patients who are not candidate for acotiamide treatment.
2. Patients who are judged as being inappropriate for this study by their medical doctors.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Takayanagi |
Organization
Graduate School of Medical Sciences,
Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city, 812-8582, Japan
TEL
81-92-642-5286
takayana@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eikichi Ihara |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city, 812-8582, Japan
TEL
81-92-642-5286
Homepage URL
eikichi@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Bioregulatory, ScienceGraduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Bioregulatory, ScienceGraduate School of Medical Sciences, Kyushu University
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
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Acotiamide (300mg/day) was applied to the patients with functional dyspepsia and esophageal motility disorders for 4 weeks. Then we prospectively examine effects of acotiamide on esophageal motility disorders.
Management information
Registered date
| 2014 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017724
