UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058984 |
|---|---|
| Receipt number | R000067366 |
| Scientific Title | Exploratory Clinical Study of Time to Onset of Glucagon Effect by Administration Route in Colonoscopy |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/03 19:59:40 |
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Basic information
Public title
Exploratory Clinical Study of Time to Onset of Glucagon Effect by Administration Route in Colonoscopy
Acronym
Exploratory Clinical Study of Time to Onset of Glucagon Effect by Administration Route in Colonoscopy
Scientific Title
Exploratory Clinical Study of Time to Onset of Glucagon Effect by Administration Route in Colonoscopy
Scientific Title:Acronym
Exploratory Clinical Study of Time to Onset of Glucagon Effect by Administration Route in Colonoscopy
Region
| Japan |
Condition
Condition
Patients scheduled for colonoscopy under sedation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The onset of peristaltic inhibition after glucagon administration was evaluated endoscopically to determine the optimal timing for colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to onset of peristalsis inhibition after intramuscular and intravenous administration of glucagon
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intramuscular administration of glucagon
Interventions/Control_2
Intravenous administration of glucagon
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled for colonoscopy under sedation
2.Patients who provided written informed consent to participate in the study
3.Patients aged 20 years or older and younger than 75 years at the time of enrollment
4.Patients scheduled to receive glucagon as an antispasmodic agent
Key exclusion criteria
1.Patients with contraindications to glucagon
2.Patients with inflammatory bowel disease
3.Patients with a history of colorectal surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Okagawa |
Organization
Sapporo Medical University School of Medicine
Division name
Division of Medical Oncology
Zip code
0118543
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
08046035753
okagawayutaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Okagawa |
Organization
Sapporo Medical University School of Medicine
Division name
Division of Medical Oncology
Zip code
0118543
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
08046035753
Homepage URL
okagawayutaka@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Yutaka Okagawa
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
0116112111
okagawayutaka@sapmed.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 | 09 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067366
