UMIN-CTR Clinical Trial

Basic information
Public title	Comparison in clinical effect of conventional NSAIDs versus open-label placebos on patients with chronic pain.
Acronym	Open-label placebo traial for chronic pain.
Scientific Title	Randomized noninferiority trial of conventional NSAIDs versus open-label placebos in patients with chronic pain.
Scientific Title:Acronym	Open-label placebo trial for chronic pain.
Region	Japan

Condition
Condition	Chronic Pain
Classification by specialty	Orthopedics Anesthesiology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the effect of open-label placebo is not inferior to that of conventional NSAIDs on patients with chronic pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Numerical rating scale
Key secondary outcomes	Pain Disability Assessment Scale EuroQol-5dimensions

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Conventional NSAIDs
Interventions/Control_2	Open-label placebos
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects who have had chronic pain for more than 3 months and voluntary participation in the study. 2. Subjects who take loxoprofen or celecoxib for more than 3 months 3. Pain intensity is more than one out of 10.
Key exclusion criteria	1. Age<20, or >84 years old. 2. Disagree with participating in the study. 3. Under treatment of malignant tumors, vertebral fractures, and infections. 4. Within 3 months after any surgeries. 5. Under treatment of dementia 6. Suspect of cognitive impairment 7. Persons who investigators regard as inappropriate for participation.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name TATSUNORI Middle name Last name IKEMOTO
Organization	Aichi Medical University
Division name	Dept of Orthopaedics
Zip code	480-1195
Address	1-1 Yazako Karimata
TEL	+81561631087
Email	tatsunon31-ik@umin.ac.jp

Public contact
Name of contact person	1st name TATSUNORI Middle name Last name IKEMOTO
Organization	Aichi medical university
Division name	Dept of Orthopaedics
Zip code	480-1195
Address	1-1 Yazako Karimata
TEL	+81561611809
Homepage URL
Email	tatsunon31-ik@umin.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	The Hori Sciences and Arts Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Aichi medical university
Address	1-1 Yazako Karimata
Tel	0561-62-3311
Email	amu_ethics@aichi-med-u.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	2019 Year 09 Month 21 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	2019 Year 06 Month 05 Day
Date of IRB	2019 Year 07 Month 11 Day
Anticipated trial start date	2019 Year 07 Month 11 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	2019 Year 09 Month 21 Day
Last modified on	2019 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042887