UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011260
Receipt No. R000013196
Scientific Title A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Date of disclosure of the study information 2013/08/01
Last modified on 2014/01/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Acronym A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Scientific Title A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Scientific Title:Acronym A study on the effect of acotiamide on esophageal motor function and gastro-esophageal reflux
Region
Japan

Condition
Condition Gastroesophageal reflux disease (GERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of acotiamide on esophageal motor function and gastro-esophageal reflux in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes evaluation of esophageal motor function and gastro-esophageal reflux after administration of acotiamide for one week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 acotiamide 3 times a day for 1 week-for 1 week- no administration for 1 week
Interventions/Control_2 no administration for 1 week- for 1 week- acotiamide 3 times a day for 1 week
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. healthy adults
2. subjects with written informed consent
Key exclusion criteria 1. subjects with a history of allergy for drugs
2. subjects with a history of allergy for anesthetic drug
3. subjects with a history of gastrectomy and/or vagotomy
4. subjects undergoing treatment with some disease
5. Others who are not eligible for participation judged by a doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501
TEL 0853-20-2190
Email kinosita@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihisa Ishimura
Organization Shimane University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501
TEL 0853-20-2190
Homepage URL
Email ishimura@med.shimane-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 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 Completed
Date of protocol fixation
2013 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 24 Day
Last modified on
2014 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.