UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056948 |
|---|---|
| Receipt number | R000065078 |
| Scientific Title | Retrospective observational study on morning colonoscopy with SULPREP |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2025/02/06 16:59:33 |
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Basic information
Public title
Retrospective observational study on morning colonoscopy with SULPREP
Acronym
MC-SUL
Scientific Title
Retrospective observational study on morning colonoscopy with SULPREP
Scientific Title:Acronym
MC-SUL
Region
| Japan |
Condition
Condition
Patients scheduled for colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether morning colonoscopy (performing colonoscopy in the morning, MS) can be performed by the two-time method with SULPREP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients who were able to perform MS by pretreatment of two-time method with SULPREP
Key secondary outcomes
(1) Patient's age, gender, and regular use of constipation medication
(2) Time from the arrival to the hospital until MS could be started
(3) Amount of SULPREP and water taken
(4) Degree of washing during colonoscopy
(5) Adverse events
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients under 70 years old with no history of abdominal surgery, attempted MS for screening and pretreated by two-time method with SULPREP
Key exclusion criteria
SULPREP administration is contraindicated in patients with a history of hypersensitivity to any of the components of this drug, gastrointestinal obstruction or suspected intestinal obstruction, intestinal perforation, gastric evacuation failure, toxic megacolon, severe renal dysfunction (creatinine clearance less than 30 mL/min), patients who cannot come to the hospital on the morning of the colonoscopy, and patients who cannot correctly understand the dosage and administration of SULPREP
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakayama |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
anakayama34@keio.jp
Sponsor or person
Institute
Keio university hospital
Institute
Department
Personal name
Funding Source
Organization
Fuji Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Keio university school of medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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
| 2025 | Year | 02 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065078
