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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name