UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038083 |
|---|---|
| Receipt number | R000043404 |
| Scientific Title | Impact of Non-Steroidal Anti-Inflammatory Drugs administration on renal function |
| Date of disclosure of the study information | 2019/09/23 |
| Last modified on | 2019/09/23 17:43:26 |
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Basic information
Public title
Impact of Non-Steroidal Anti-Inflammatory Drugs administration on renal function
Acronym
Impact of NSAIDs administration on renal function
Scientific Title
Impact of Non-Steroidal Anti-Inflammatory Drugs administration on renal function
Scientific Title:Acronym
Impact of NSAIDs administration on renal function
Region
| Japan |
Condition
Condition
Chronic musculoskeletal pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate whether switch from Nonsteroidal anti-inflammatory drugs (NSAIDs) administration to tramadol hydrochloride/acetaminophen (TA) combination tablets reverse renal side effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated Glomerular Filtration Rate (eGFR)
Key secondary outcomes
Glutamic Oxaloacetic Transaminase (GOT), and Glutamic Pyruvic Transaminase (GPT)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Chronic musculoskeletal pain
Key exclusion criteria
Cancer related pain, presence of neurological signs, evidence of bone fractures, underwent surgery within 6 months, positive pregnancy test, American Society of Anesthesiologists (ASA) physical status at least 3
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
543-0027
Address
2-75 Fudegasaki Tennoji, Osaka
TEL
06-6771-1227
hisyohayaishi@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
543-0027
Address
2-75 Fudegasaki Tennoji, Osaka
TEL
06-6771-1227
Homepage URL
hisyohayaishi@gmail.com
Sponsor or person
Institute
Hayaishi Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Amagasaki Chuou Hospital
Address
1-12-1 Shioe, Amagasaki
Tel
06-6499-3045
info@chuoukai.or.jp
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
| 2019 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation whether switch from Nonsteroidal anti-inflammatory drugs (NSAIDs) administration to tramadol hydrochloride/acetaminophen (TA) combination tablets reverse renal side effects
Management information
Registered date
| 2019 | Year | 09 | Month | 23 | Day |
Last modified on
| 2019 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043404
