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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030534
Receipt No. R000034859
Scientific Title The Effect of Trimebutine Maleate in Capsule Enteroscopy
Date of disclosure of the study information 2017/12/23
Last modified on 2017/12/23

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Basic information
Public title The Effect of Trimebutine Maleate in Capsule Enteroscopy
Acronym The Effect of Trimebutine Maleate in Capsule Enteroscopy
Scientific Title The Effect of Trimebutine Maleate in Capsule Enteroscopy
Scientific Title:Acronym The Effect of Trimebutine Maleate in Capsule Enteroscopy
Region
Japan

Condition
Condition small bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of trimebutine maleate on gastrointestinal transit time and diagnostic yield of capsule endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastrointestinal transit time of capsule endoscopy.
Key secondary outcomes diagnostic yield of capsule endoscopy.
Field of clearly view in the gastrointestinal tract.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 the trimebutine maleate group
Interventions/Control_2 the control group
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent CE
patients who had Chronic gastritis or Irritable bowel syndrome
Key exclusion criteria Severe liver dysfunction,
pregnancy,
Patients taking of trimebutine maleate at registration
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryu Nishiyama
Organization Hiratsuka kyosai hospital
Division name Department of Gastroenterology
Zip code
Address Oiwake9-11,Hiratsuka-shi,Kanagawa,Japan
TEL 0463-32-1950
Email ryuwest@mb.infoweb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryu Nishiyama
Organization Hiratsuka kyosai hospital
Division name Department of Gastroenterology
Zip code
Address Oiwake9-11,Hiratsuka-shi,Kanagawa,Japan
TEL 0463-32-1950
Homepage URL
Email ryuwest@mb.infoweb.ne.jp

Sponsor
Institute Hiratsuka kyosai hospital
Department of Gastroenterology
Institute
Department

Funding Source
Organization Hiratsuka kyosai hospital
Department of Gastroenterology
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 国家公務員共済組合連合会 平塚共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 23 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
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 04 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
2017 Year 12 Month 23 Day
Last modified on
2017 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034859

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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