UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025797 |
|---|---|
| Receipt number | 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 14:16:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kenkyu@pain.med.osaka-u.ac.jp
Sponsor or person
Institute
Japanese assocation for the study of muskuloskeletal pain, division of clinical reaseach
Institute
Department
Personal name
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
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
Value
https://center6.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 |
