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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005802
Receipt No. R000006866
Scientific Title Utilization study of oral flagyl@
Date of disclosure of the study information 2011/06/19
Last modified on 2012/02/21

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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 Obsterics 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
Email

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
Email mikamo@aichi-med-u.ac.jp

Sponsor
Institute Department of Infection Control and Prevention, Aichi Medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006866

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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