UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038070 |
|---|---|
| Receipt number | R000042887 |
| Scientific Title | Randomized noninferiority trial of conventional NSAIDs versus open-label placebos in patients with chronic pain. |
| Date of disclosure of the study information | 2019/09/21 |
| Last modified on | 2019/09/21 09:09:30 |
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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
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
tatsunon31-ik@umin.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042887
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
