UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022120 |
|---|---|
| Receipt number | R000025501 |
| Scientific Title | Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2016/04/28 15:34:42 |
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Basic information
Public title
Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis
Acronym
Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis
Scientific Title
Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis
Scientific Title:Acronym
Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis
Region
| Japan |
Condition
Condition
lumbar canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of tramadol- acetaminophen combination tablets for the pain of the patient with lumbar canal stenosis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL associated with lumbar back pain and intermittent claudication
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
6 weeks oral administration of tramadol / acetaminophen combination tablets
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
The patient who have continious pain or numbness due to lumbar canal steosis
The patient who has intermittent caludication (less than 30 minutes or 2 km)
Key exclusion criteria
The patient who have serious disorder
The patient who have malignant tumor
The patient who have mental disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morio Matsumoto |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
morio@a5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Fujita |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nfujita2007@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2016 | Year | 05 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 28 | 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
| 2016 | Year | 04 | Month | 28 | Day |
Last modified on
| 2016 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025501
