UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022087 |
|---|---|
| Receipt number | R000025467 |
| Scientific Title | A comparative study on the usefulness of midazolam and pethidine in esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2019/05/02 16:39:03 |
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Basic information
Public title
A comparative study on the usefulness of midazolam and pethidine in esophagogastroduodenoscopy
Acronym
A comparative study on the usefulness of midazolam and pethidine in esophagogastroduodenoscopy
Scientific Title
A comparative study on the usefulness of midazolam and pethidine in esophagogastroduodenoscopy
Scientific Title:Acronym
A comparative study on the usefulness of midazolam and pethidine in esophagogastroduodenoscopy
Region
| Japan |
Condition
Condition
Patients requiring upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the visibility of the esophagogastric junction and the tolerability in patients when upper gastrointestinal endoscopy is performed with midazolam or pethidine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of patients whose esophagogastric junction could be observed circumferentially
Key secondary outcomes
The tolerability of the examination, duration of the examination, procedural accidents, number of neoplastic lesions detected, and with/without sufficient observability of the lower pharynx
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
esophagogastroduodenoscopy with midazolam
Interventions/Control_2
esophagogastroduodenoscopy with pethidine
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients evaluated by esophagogastroduodenoscopy
Key exclusion criteria
patients with midazolam or pethidine allergy.
patients who have been judged as inappropriate for this study
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Matsuo |
Organization
St. Marianna University School of Medicine
Division name
Gastroenterology and hepatology division
Zip code
216-8511
Address
2-16-1Sugao Miyamae-ku Kawasaki-shi Kanagawa
TEL
0449778111
yasumasa_matsuo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasumasa |
| Middle name | |
| Last name | Matsuo |
Organization
St. Marianna University School of Medicine
Division name
Gastroenterology and hepatology division
Zip code
216-8511
Address
2-16-1Sugao Miyamae-ku Kawasaki-shi Kanagawa
TEL
0449778111
Homepage URL
yasumasa_matsuo@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1Sugao Miyamae-ku Kawasaki-shi Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-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 | 04 | Month | 27 | 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
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 05 | 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 | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025467
