UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of a new preparation regimen in colon capsule endoscopy
Acronym	A new preparation regimen in colon capsule endoscopy
Scientific Title	Evaluation of a new preparation regimen in colon capsule endoscopy
Scientific Title:Acronym	A new preparation regimen in colon capsule endoscopy
Region	Japan

Condition
Condition	Asymptomatic volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of a new preparation regimen in colon capsule endosocpy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	capsule excretion rate
Key secondary outcomes	feelings during and after prepation

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Standard preparation regimen in Europe
Interventions/Control_2	New preparation regimen
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	Volunteers who are able to write a consent form
Key exclusion criteria	1. Subjects who have dysphagia or aspiration pneumonia 2. Subjects who have history of surgery in gastrointestinal tract 3. Subjects who may have gastrointestinal obstruction 4. Subjects who have toxic megacolon 5. Subjects who have hypertension or renal failure 6. Subjects who have congestive heart failure or unstable angina 7. Subjects who have long QT syndrome or serious arrythmia 8. Subjects who have ascites 9. Subjects who have electrolyte imbalance 10. Subjects who have delayed gastric emptying 11. Subjects who have pacemaker or implantable cardioverter-defibrillator 12. Subjects who have allergy for drugs and foods used in the study 13. Subjects who are pregnant and who are breast-feeding 14. Subjects who are not suitable for the study
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	0272208137
Email	shikokuri@gunma-u.ac.jp

Public contact
1st name of contact person	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	0272208137
Homepage URL
Email	shikokuri@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Gunma University Hospital Department of Gastroenterology and Hepatology
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	Gunma University Hospital
Address	3-39-15 Showa-machi, Maebashi, Gunma
Tel	027-220-8137
Email	shikokuri@gunma-u.ac.jp

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	2016 Year 09 Month 20 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	1
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	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 15 Day
Last modified on	2019 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027705