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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025797
Receipt No. R000029548
Scientific Title The effects on two conventional medication, acetaminophen and loxoprofen, for musculoskeletal pain including neck pain, low back pain, and knee pain. -multicenter longitudinal study -
Date of disclosure of the study information 2017/01/23
Last modified on 2019/01/25

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Basic information
Public title The effects on two conventional medication, acetaminophen and loxoprofen, for musculoskeletal pain including neck pain, low back pain, and knee pain.
-multicenter longitudinal study -
Acronym The effects on two conventional medication for musculoskeletal pain
Scientific Title The effects on two conventional medication, acetaminophen and loxoprofen, for musculoskeletal pain including neck pain, low back pain, and knee pain.
-multicenter longitudinal study -
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenji Miki
Organization Osaka University
Division name Department of Pain Medicine
Zip code
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
1st name
Middle name
Last name Kenji Miki
Organization Osaka University
Division name Department of Pain Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0949265818300496
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029548

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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