UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039719 |
|---|---|
| Receipt number | R000045300 |
| Scientific Title | Randomized open-labbel non-inferiority trial of paracetamol or celecoxib for patients with chronic low back pain - multicenter longitudinal study - |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2020/03/07 01:08:42 |
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Basic information
Public title
Randomized open-labbel non-inferiority trial of paracetamol or celecoxib for patients with chronic low back pain - multicenter longitudinal study -
Acronym
The effects on two conventional medication for chronic low back pain
Scientific Title
Randomized open-labbel non-inferiority trial of paracetamol or celecoxib for patients with chronic low back pain - multicenter longitudinal study -
Scientific Title:Acronym
The effects on two conventional medication for chronic low back pain
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects on two conventional medication, acetaminophen and celecoxib for chronic low back pain and to consider clinical significance of the usage of these medication.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bio-equivalence of the effects on two conventional medications for pain reduction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of acetaminophen 1,000 mg/time, three times a day, for 4 weeks
Interventions/Control_2
Oral administration of celecoxib 100 mg/time, two times a day, for 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The subjects who complain of following chronic low back pain.
2) The subjects who can agree to participate in this study.
Key exclusion criteria
1) The subjects just seek second opinion.
2) History of malignant disease.
3) The subjects with neuropathic pain.
4) The subjects with surgical histories within six month.
5) The subjects considered inappropriate by the attending doctor.
Target sample size
186
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
543-0027
Address
2-75 Fudegasaki Tennoji, Osaka, 543-0027, Japan
TEL
06-6771-1227
hisyohayaishi@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
543-0027
Address
2-75 Fudegasaki Tennoji, Osaka, 543-0027, Japan
TEL
06-6771-1227
Homepage URL
hisyohayaishi@gmail.com
Sponsor or person
Institute
Hayaishi Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese assocation for the study of muskuloskeletal pain
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hayaishi Hospital
Address
2-75 Fudegasaki Tennoji, Osaka, 543-0027, Japan
Tel
06-6771-1227
info@hayaishi.or.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
| 2020 | Year | 03 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045300
| Research Plan | |
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| 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 |
