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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010966
Receipt No. R000012834
Scientific Title Comparison of gastric and small-bowel transit time between Acotiamide, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Date of disclosure of the study information 2013/07/26
Last modified on 2014/12/15

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Basic information
Public title Comparison of gastric and small-bowel transit time between Acotiamide, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Acronym Comparison of gastric and small-bowel transit time between Acotiamide, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Scientific Title Comparison of gastric and small-bowel transit time between Acotiamide, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Scientific Title:Acronym Comparison of gastric and small-bowel transit time between Acotiamide, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Acotiamide hydrochloride trihydrate (acotiamide) is a novel gastric motility modulator currently being developed for the treatment of FD. Acotiamide also inhibits acetylcholinesterase (AChE) activity, and thus, the inhibitory action of AChE might be involved in the prokinetic activity.
We study that comparison of gastric and small-bowel transit time between Acotiamide, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gastric and small-bowel transit time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 The group who takes Acotiamide 100mg
Interventions/Control_2 The group who takes Placebo
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
Key inclusion criteria Patient who fills everything the following
1) Patient of 20 years or more
2) Patient who gives written informed consent
Key exclusion criteria The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Subjects with malignancy
3)Others
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL 045-787-2800
Email nakajima-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Inamori
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL 045-787-2800
Homepage URL
Email inamorim@med.yokohama-cu.ac.jp

Sponsor
Institute Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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 07 Month 26 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
2013 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 26 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 06 Month 14 Day
Last modified on
2014 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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