UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007848 |
|---|---|
| Receipt number | R000009246 |
| Scientific Title | Survey of Usage Monitoring of Midazolam and Arousal Level of Flumazenil in Endoscopy |
| Date of disclosure of the study information | 2012/04/27 |
| Last modified on | 2012/04/27 15:29:20 |
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Basic information
Public title
Survey of Usage Monitoring of Midazolam and Arousal Level of Flumazenil in Endoscopy
Acronym
Survey of Usage Monitoring of Midazolam and Flumazenil in Endoscopy
Scientific Title
Survey of Usage Monitoring of Midazolam and Arousal Level of Flumazenil in Endoscopy
Scientific Title:Acronym
Survey of Usage Monitoring of Midazolam and Flumazenil in Endoscopy
Region
| Japan |
Condition
Condition
Disease of the need for Gastrointestinal Endoscopy
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of usage monitoring of Midazolam, and analysis of relationship with patient background.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship with drinking history, drug history and BMI
Key secondary outcomes
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Range in age from 20 to 60
Key exclusion criteria
1)Case where no consent is obtained.
2)Contraindication or caution to Midazolam or Flumazenil.
3)Acute disease(infection,gastrointestinal bleeding etc.).
4)Therapeutic purpose.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nagasawa |
Organization
Chiba Pharmaceutical Association
Division name
Drug Information Center
Zip code
Address
9-2 Tonyacho, Chuo-ku, Chibashi, Chiba 260-0026, Japan
TEL
(043)247-4401
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nagasawa |
Organization
Secomedic Hospital
Division name
Dispensary
Zip code
Address
696-1 Toyotomicho, Funabashishi, Chiba 274-0053, Japan
TEL
(047)457-9255
Homepage URL
h-nagasawa@secomedic.gr.jp
Sponsor or person
Institute
Secomedic Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba Pharmaceutical Association
Drug Information Center
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
医療法人社団誠馨会 セコメディック病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Ju MIZUNO,Michiko MATSUKI,Yoshinori GOUDA,et al.Antagonizing with Flumazenil after Sedation with Midazolam in Uppr Gastrointestinal Endoscopy.2004;52-5:823-830
Management information
Registered date
| 2012 | Year | 04 | Month | 27 | Day |
Last modified on
| 2012 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009246
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
