UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects on two conventional medication, acetaminophen and loxoprofen, for musculoskeletal pain including neck pain, low back pain, and knee pain. -multicenter longitudinal study -
Title of the study (Brief title)	The effects on two conventional medication for musculoskeletal pain
Region	Japan

Condition
Condition	Musculoskeletal 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 loxoprofen for acute musculoskeletal pain and to consider clinical significance of the usage of these medication.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Bio-equivalence of the effects on two conventional medications for pain reduction in musculoskeletal pain.
Key secondary outcomes	Pain Disability Assessment Scale, Hospital Anxiety and Depression Scale, Pain Catastrophizing Scale, Work Productivity and Activity Impairment, Euro-QOL 5 Dimension, Adverse effect, Laboratory examination.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of loxoprofen 60 mg/time, three times a day, for 1 month.
Interventions/Control_2	Oral administration of Acetaminophen 600 mg/time, four times a day, for 1 month
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 musculoskeletal pain; neck pain, low back pain, and knee pain, within four weeks after the onset of an acute pain episode. 2)The subjects are in-patients clinic or out-patients clinic. 3)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 surgical histories within six month. 4)The subjects considered inappropriate by the attending doctor.
Target sample size	310

Research contact person
Name of lead principal investigator	Kenji Miki
Organization	Osaka University
Division name	Department of Pain Medicine
Address	2-2 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan
TEL	06-6879-3745
Email	kenkyu@pain.med.osaka-u.ac.jp

Public contact
Name of contact person	Kenji Miki
Organization	Osaka University
Division name	Department of Pain Medicine
Address	2-2 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan
TEL	06-6879-3745
Homepage URL	http://www.jamp.so/information/img/setsumei.pdf
Email	kenkyu@pain.med.osaka-u.ac.jp

Sponsor
Institute	Japanese assocation for the study of muskuloskeletal pain, division of clinical reaseach
Institute
Department

Funding Source
Organization	Japanese assocation for the study of muskuloskeletal pain, division of clinical reaseach
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

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	2017 Year 01 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 09 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.sciencedirect.com/science/article/pii/S0949265818300496
Results	The results suggest that acetaminophen has comparable analgesic effects on acute LBP, based on at least a noninferiority margin, compared with loxoprofen at 4 weeks. Acetaminophen seems to be a reasonable first-line option for patients with acute LBP in Japan.
Other related information

Management information
Registered date	2017 Year 01 Month 23 Day
Last modified on	2019 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029548