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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014620
Receipt No. R000016796
Scientific Title Preventive effect of minocycline on postoperative cognitive dysfunction in Japanese elderly patients: A randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2014/07/24
Last modified on 2018/08/08

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Basic information
Public title Preventive effect of minocycline on postoperative cognitive dysfunction in Japanese elderly patients: A randomized, double-blind, placebo-controlled trial
Acronym MINOPOC-J
Scientific Title Preventive effect of minocycline on postoperative cognitive dysfunction in Japanese elderly patients: A randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym MINOPOC-J
Region
Japan

Condition
Condition The elderly patient who undergoes total knee arthroplasty(TKA)
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is investigating whether minocycline has a preventive effect on postoperative cognitive dysfunction (POCD). We are going to give minocycline or placebo to elderly patients undergoing TKA to compare the cognitive function before and ater surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We are going to evaluate the cognitive function 1 week and 3 months after the surgery to test whether minocycline can decrease the incidence of POCD.
Key secondary outcomes We are going to compare the incident rate of delirium between minocycline and placebo group within 1 week after surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of 200 mg minocycline per day from 1 day before to 7 days after surgery
Interventions/Control_2 Administration of a placebo(sugar) from 1 day before to 7 days after surgery
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
60 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) The patient who has a score of 15 or more in MoCA-J test
2) The patient with PS1 or PS2
3) The patient gave written informed consent
Key exclusion criteria 1)The patient with the mental disease
2)The patient with the drug dependency or alcoholism
3)The patient with cardiac disease
4)The patient with hepatic disease
5)The patient with renal disease
6)The patient with allergy to tetracycline
including minocycline
7)The patient taking calcium, magnesium, aluminum, lantern, iron medicine, anticoagulant,sulfonylurea-based hypoglycemic drug, methotrexate, porfimer sodium, digoxin,oral contraceptive, vitamine A
8)The patient to whom a doctor judged inappropriate for participating in this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori TAKAZAWA
Organization Gunma University Hospital
Division name Intenisive Care Unit
Zip code
Address 3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL 027-220-8698
Email takazawt@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori TAKAZAWA
Organization Gunma University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL 027-220-8454
Homepage URL
Email takazawt@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital, Department of Anesthesiology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 群馬中央病院(群馬県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 24 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016796

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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