UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017510 |
|---|---|
| Receipt number | R000020266 |
| Scientific Title | Usefulness and safety of Tramadol Hydrochloride Acetaminophen Combination Table in musculoskeletal system with chronic pain,a prospective and multicenter study |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/05/11 23:59:06 |
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Basic information
Public title
Usefulness and safety of Tramadol Hydrochloride Acetaminophen
Combination Table in musculoskeletal system with chronic pain,a prospective and multicenter study
Acronym
Usefulness of Tramadol Hydrochloride Acetaminophen Combination Tablet
Scientific Title
Usefulness and safety of Tramadol Hydrochloride Acetaminophen
Combination Table in musculoskeletal system with chronic pain,a prospective and multicenter study
Scientific Title:Acronym
Usefulness of Tramadol Hydrochloride Acetaminophen Combination Tablet
Region
| Japan |
Condition
Condition
musculoskeletal system with chronic pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of Tramadol Hydrochloride Acetaminophen Combination Tablet
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric Rating Scale
EQ-5D
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tramadol Hydrochloride Acetaminophen Combination Tablet
Interventions/Control_2
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
Subjects with symptomatic patients who experienced at least moderate pain (NRS score is at least 4) despite treatment with non-steroidal anti-inflammatory drugs
Key exclusion criteria
Exclusion criteria included a history of alcohol or drug abuse; or any known allergy, sensitivity, or contraindication to a study medication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate school of medicine,
Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
sohtri@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate school of medicine,
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
sohtri@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Orthopeadic Surgery ,
Graduate school of medicine,
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopeadic Surgery ,
Graduate school of medicine,
Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2015 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020266
