UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013066 |
|---|---|
| Receipt number | R000015233 |
| Scientific Title | Analgesic effects of Ivabradine in healthy volunteers |
| Date of disclosure of the study information | 2014/02/20 |
| Last modified on | 2022/02/09 09:11:05 |
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Basic information
Public title
Analgesic effects of Ivabradine in healthy volunteers
Acronym
Analgesic effects of Ivabradine
Scientific Title
Analgesic effects of Ivabradine in healthy volunteers
Scientific Title:Acronym
Analgesic effects of Ivabradine
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate analgesic effects of Ivabradine, a HCN channel blocker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the increase in the mechanical, thermal, and electrical pain thresholds after oral administration of Ivabradine.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of Ivabradine
Interventions/Control_2
Oral administration of placebo
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy humans
Key exclusion criteria
chronic pain
analgesics within one month
Electrocardiogram abnormality
History of heart failure
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanaka |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2670
s_tanaka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanaka |
Organization
Shinshu University School of Medicine
Division name
Department Anesthesiology and Resuscitology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
s_tanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015233
