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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039719
Receipt No. 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

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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
Email 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
Email hisyohayaishi@gmail.com

Sponsor
Institute Hayaishi Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045300

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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