UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014620 |
|---|---|
| Receipt number | 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 | 2020/05/22 15:05:33 |
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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 | Tomonori |
| Middle name | |
| Last name | TAKAZAWA |
Organization
Gunma University Hospital
Division name
Intenisive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL
027-220-8698
takazawt@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | TAKAZAWA |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL
027-220-8454
Homepage URL
takazawt@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital, Department of Anesthesiology
Institute
Department
Personal name
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8740
gunmaciru-office@umin.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
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2014 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016796
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