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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001888
Receipt No. R000002271
Scientific Title Effect of Daikenchuto as a preparation for capsule endoscopy (Study for patients who had incomplete capsule endoscopy)
Date of disclosure of the study information 2009/04/14
Last modified on 2011/10/14

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Basic information
Public title Effect of Daikenchuto as a preparation for capsule endoscopy
(Study for patients who had incomplete capsule endoscopy)
Acronym Effect of Daikenchuto as a preparation for second capsule endoscopy
Scientific Title Effect of Daikenchuto as a preparation for capsule endoscopy
(Study for patients who had incomplete capsule endoscopy)
Scientific Title:Acronym Effect of Daikenchuto as a preparation for second capsule endoscopy
Region
Japan

Condition
Condition Suspected small intestinal disease such as obscure gastrointestinal bleeding
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of Daikenchuto as a preparation for capsule endoscopy for small intestinal disease such as obscure gastrointestinal bleeding.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) gastric emptying time
2) small bowel transit time
3) cecum completion rate
Key secondary outcomes To evaluate the following image qualities
1) degree of residues
2) degree of air bubbles
3) clearness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Preparation using Daikenchuto (15g/day) for 3days including the examination day.
Interventions/Control_2 no preparation
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) 20 years-old and above
2) Patients who can provide written informed consent
3) The history ofthe previous capsule which could not reach to cecum
4) In principle, patients who have not changed medicines from previous examination within 3 months.
Key exclusion criteria 1) Patients with dysphagia.
2) Pregnant
3) Patients who have history of the ileus or stricture or fistula of the intestine.
4) Patients with pacemaker or other medical electronic devices.
5) Patients who participate with any other clinical test/trial which will affect the results this study.
6) Patients who can not comply with the study requirements or can not follow instructions for the device.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Haruma
Organization Kawasaki Medical School
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawasaki Medical School
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
2009 Year 04 Month 14 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 Terminated
Date of protocol fixation
2009 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 14 Day
Last modified on
2011 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002271

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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