UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001888 |
|---|---|
| Receipt number | 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 18:46:54 |
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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
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
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002271
