UMIN-CTR Clinical Trial

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
Email	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
Email	yoshinuma.hiromi@kameda.jp

Sponsor
Institute	Kameda Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049993