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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002562
Receipt No. R000002342
Scientific Title Reviewing of the bowel preparation for Colon Capsule Endoscopy
Date of disclosure of the study information 2009/10/13
Last modified on 2010/05/02

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Basic information
Public title Reviewing of the bowel preparation for Colon Capsule Endoscopy
Acronym Colon Capsule Preparation Study
Scientific Title Reviewing of the bowel preparation for Colon Capsule Endoscopy
Scientific Title:Acronym Colon Capsule Preparation Study
Region
Japan

Condition
Condition Subjects who undergo Colon Capsule Endoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify whether Japanese specific colon preparation method can obtain the same good cleansing level and a high anus excretion rate as the oversea methods
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Colon cleansing level and anus excretion rate
Key secondary outcomes Transit time in total digestive tract

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 A group
Day before test: No administration of Polyethylene glycol(PEG).
Test day: Administer PEG (2L).
After completion of preparation, Colon Capsule procedure starts.
Interventions/Control_2 B group
Day before test: Administer Polyethylene glycol (PEG) (2L) in the evening.
Test day: Administer PEG (1L).
After completion of preparation, Colon Capsule procedure starts.
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
18 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria - Patients who have planned to undergo Colon Capsule procedure, or asymptomatic healthy volunteers
- Obtaining informed consent
Key exclusion criteria 1) Subjects who have a swallowing disorder
2) Subject who has 2 < bowel movements per week.
3) Subjects who take nonsteroidal anti-inflammatory drug for long period (more than 6 months)
4) Subjects who take anti-thrombotic medicine or anticoagulant
5) Subjects who take iron pills
6) Subjects who take morphine hydrochloride
7) Subjects who take tranquilizers
8) Subjects who have a history of allergic reaction to the following medicines (1 - 4) used in this study. These medicines are used normally in the clinical situations in Japan.
1. Magnesium citrate solution, Polyethylene glycol 2. Mosapride citrate 3. Dimethicone, Pronase, Sodium bicarbonate 4. Bisacodyl 5.Glycerin 6.sennoside
9) Subjects who are pregnant
10) Subjects who are scheduled to have MRI examination within the next 2 weeks
11) Subjects who have a cardiac pacemaker implanted or other medical electronic devices applied in the body
12) Subjects who have a history of digestive tract anastomosis
13) Subjects who have a history of abdominal operation
14) Subjects who have a suspected symptom or who have a history of intestinal obstruction or intestinal stenosis
15) Subjects who have a small intestine tumor or who have a suspected symptom of it
16) Subjects who have an advanced large intestine cancer or who have a suspected symptom of it
17) Subjects who have a diabetes
18) Subjects who have a diverticulum in digestive tract
19) Subjects who have a history of radiotherapy
20) Subjects who have an accompanying cancerous peritonitis
21) Subjects who have a renal dysfunction
22) Subjects who have a heart disease
23) Subjects who have a clone disease or ulcerative colitis
24) Subjects who have a familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
25) Subjects who had a incomplete total colonoscopy before
26) Other cases where doctor considers it inappropriate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Saito
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Kakugawa
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code
Address
TEL 03-3542-2511
Homepage URL
Email

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Jikei University School of Medicine, Nagoya University, Osaka City University, Osaka Medical College, Hiroshima University
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 10 Month 13 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 Completed
Date of protocol fixation
2009 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 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 09 Month 29 Day
Last modified on
2010 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002342

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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