UMIN-CTR Clinical Trial

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