UMIN-CTR Clinical Trial

Basic information
Public title	Perioperative duloxetine administration reduces pain after high tibial osteotomy and non-steroidal anti-inflammatory administration
Acronym	The effect of perioperative duloxetine administration for pain reduction
Scientific Title	Perioperative duloxetine administration reduces pain after high tibial osteotomy and non-steroidal anti-inflammatory administration
Scientific Title:Acronym	The effect of perioperative duloxetine administration for pain reduction
Region	Japan

Condition
Condition	osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether perioperative duloxetine administration reduces pain after knee surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Numeric rating scale
Key secondary outcomes	Pain catastrophizing Scale Knee Injury and Osteoarthritis Outcome Score (KOOS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in the duloxetine group received one 20-mg capsule once daily for 1 week at 3 weeks before surgery and two 20-mg capsules once daily for 2 weeks before surgery.
Interventions/Control_2	Patients received non-steroidal anti-inflammatory drugs (NSAIDs; 60 mg) for severe pain, and three tablets per day were permitted as the maximum dose.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Osteoarthritis
Key exclusion criteria	Rheumatoid arthritis
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Shuhei Middle name Last name Otsuki
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of orthopedic surgery
Zip code	569-8686
Address	2-7 Daigakumachi Takatsuki Osaka Japan
TEL	0726831221
Email	Shuhei.otsuki@ompu.ac.jp

Public contact
Name of contact person	1st name Shuhei Middle name Last name Otsuki
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of orthopedic surgery
Zip code	569-8686
Address	2-7 Daigakumachi Takatsuki Osaka Japan
TEL	0726831221
Homepage URL
Email	Shuhei.otsuki@ompu.ac.jp

Sponsor
Institute	Department of orthopedic surgery, Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka Medical and Pharmaceutical University
Address	2-7 Daigakumachi Takatsuki Osaka Japan
Tel	0726831221
Email	Shuhei.otsuki@ompu.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

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 06 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	80
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	2019 Year 04 Month 22 Day
Date of IRB	2019 Year 07 Month 02 Day
Anticipated trial start date	2019 Year 07 Month 15 Day
Last follow-up date	2022 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	2022 Year 04 Month 06 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054080