UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043795 |
|---|---|
| Receipt number | R000049993 |
| Scientific Title | Effect of Perioperative Duloxetine Influence Postoperative Functional Recovery and Analgesia in Knee Osteoarthritis |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2021/03/31 14:30:56 |
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Basic information
Public title
Effect of Perioperative Duloxetine Influence
Postoperative Functional Recovery and Analgesia in Knee Osteoarthritis
Acronym
Effect of Perioperative Duloxetine Influence
Postoperative Functional Recovery and Analgesia in Knee Osteoarthritis
Scientific Title
Effect of Perioperative Duloxetine Influence
Postoperative Functional Recovery and Analgesia in Knee Osteoarthritis
Scientific Title:Acronym
Effect of Perioperative Duloxetine Influence
Postoperative Functional Recovery and Analgesia in Knee Osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether perioperative duloxetine influences long-term functional recovery after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Function of the knee joint 6 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group of patients taking duloxetine perioperatively
Interventions/Control_2
Group of patients not taking duloxetine perioperatively
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
Patients undergoing osteotomy for osteoarthritis of the knee
Key exclusion criteria
Patients who do not consent to the study.
Patients who are allergic to duloxetine.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Yoshinuma |
Organization
Kameda Medical Center
Division name
Department of anesthesioligy
Zip code
2968002
Address
929 Higashicho, kamogawa, Chiba, Japan
TEL
0470922211
yoshinuma.hiromi@kameda.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Yoshinuma |
Organization
Kameda Medical Center
Division name
Department of anesthesioligy
Zip code
2968602
Address
929 Higashicho, kamogawa, Chiba, Japan
TEL
0470922211
Homepage URL
yoshinuma.hiromi@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center, Research ethics committee
Address
929 Higashicho, kamogawa, Chiba, Japan
Tel
0470922211
clinical_research@kameda.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 15 | 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
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2021 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049993
