UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of acotiamide on patients with esophageal motility disorders
Title of the study (Brief title)	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	Ryoichi Takayanagi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory Science
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka city, 812-8582, Japan
TEL	81-92-642-5286
Email	takayana@intmed3.med.kyushu-u.ac.jp

Public contact
Name of contact person	Eikichi Ihara
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory Science
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka city, 812-8582, Japan
TEL	81-92-642-5286
Homepage URL
Email	eikichi@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Bioregulatory, ScienceGraduate School of Medical Sciences, Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017724