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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022087
Receipt No. 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

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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
Email 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
Email yasumasa_matsuo@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025467

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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