UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005802 |
|---|---|
| Receipt number | R000006866 |
| Scientific Title | Utilization study of oral flagyl@ |
| Date of disclosure of the study information | 2011/06/19 |
| Last modified on | 2012/02/21 14:37:23 |
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Basic information
Public title
Utilization study of oral flagyl@
Acronym
Utilization study of oral flagyl@
Scientific Title
Utilization study of oral flagyl@
Scientific Title:Acronym
Utilization study of oral flagyl@
Region
| Japan |
Condition
Condition
Anaerobic infection
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Aesthetic surgery | Laboratory medicine |
| Operative medicine | Emergency medicine | Blood transfusion |
| Intensive care medicine | Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study based on the oral metronidazole; utilization is as below.
To evaluate the efficacy and safety of oral metronidazole; in patients with anaerobic infection.
To evaluate the efficacy and safety of oral metronidazole; in patients with Clostridium difficile associated diarrhea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The Appearance of adverse drug reaction
(incidence of adverse drug reaction)
Key secondary outcomes
The Clinical evaluation
(efficacy rate)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Inpatients or outpatients who were treated with oral metronidzole for anaerobic infection
2) Inpatients or outpatients who were treated with oral metronidazole for Clostridium difficile associated diarrhea
Key exclusion criteria
None for retrospective study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshige Mikamo |
Organization
Aichi Medical University Hospital
Division name
Department of Infection Control and Prevention
Zip code
Address
21 Karimata, Yazako, Nagakute-cho, Aichi-gun, Aichi, 480-1195, Japan
TEL
0561-62-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshige Mikamo |
Organization
Aichi Medical University Hospital
Division name
Department of Infection Control and Prevention
Zip code
Address
21 Karimata, Yazako, Nagakute-cho, Aichi-gun, Aichi, 480-1195, Japan
TEL
0561-62-3311
Homepage URL
mikamo@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Infection Control and Prevention, Aichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
愛知医科大学病院（愛知県），東海大学医学部附属八王子病院（東京都），静岡がんセンター（静岡県），岐阜大学病院（岐阜県），岐阜赤十字病院（岐阜県），名古屋市立大学（愛知県），名古屋大学（愛知県），藤田保健衛生大学坂文種報徳曾病院（愛知県），トヨタ記念病院（愛知県），三重大学（三重県),奈良県立医科大学(奈良県),兵庫医科大学病院（兵庫県），広島大学病院（広島県），大分大学病院（大分県），長崎大学病院（長崎県），琉球大学医学部附属病院（沖縄県），中頭病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 19 | 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
| 2011 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Observation about items below will be investigated
Efficacy
Safety
Management information
Registered date
| 2011 | Year | 06 | Month | 19 | Day |
Last modified on
| 2012 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006866
| 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 |
