UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013041 |
|---|---|
| Receipt number | R000015218 |
| Scientific Title | Safety of bowel cleasing agents for colon capsule endoscopy and conventional colonoscopy |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2021/01/23 11:11:23 |
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Basic information
Public title
Safety of bowel cleasing agents for colon capsule endoscopy and conventional colonoscopy
Acronym
Safety of bowel cleasing agents
Scientific Title
Safety of bowel cleasing agents for colon capsule endoscopy and conventional colonoscopy
Scientific Title:Acronym
Safety of bowel cleasing agents
Region
| Japan |
Condition
Condition
Colorectal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A new low-volume, sodium phosphate-free polyethylene glycol (2-L Moviprep) has been available at conventional colonoscopy since June 2013 in Japan. Safety of Movipreps has not been well discussed at conventional colonoscopy and colon capsule endoscopy for aged patients, and patients with chronic renal or heart failure. In this study, we determine the safety of bowel cleansing agents at conventional colonoscopy and colon capsule endoscopy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Vital sign, blood and urine analysis before and after colonic examination
Key secondary outcomes
Cleasing grades, duration of bowel cleasing, and acceptablity of cleasing agents.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Male and female older than 19 years old which were diagnosed or suspected to have colorectal diseases.
Key exclusion criteria
1)Patients with dysphasia
2)Patietns who had allergy to agents used in this study.
3)Pregnant or possible pregnant women
4)Patients who will undergo MRI 2 weeks after colon capsule endoscopy
5)Patients with small and large bowel obstruction
6)Patients with stricture in small and large bowel
7)Patients with glucose-6-phosphate dehydrogenase deficiency
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi Prefecture, Japan
TEL
0562-93-9240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi Prefecture, Japan
TEL
0562-93-9240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals CO., LDT
Organization
Division
Category of Funding Organization
Profit organization
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
藤田保健衛生大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | 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
| 2013 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 06 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
57 patients with CKD were enrolled.
Management information
Registered date
| 2014 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015218
