UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023022 |
|---|---|
| Receipt number | R000026532 |
| Scientific Title | Analgesic effects of Ivabradine on inflammatory pain in healthy volunteers |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2022/03/21 21:59:19 |
* 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
Analgesic effects of Ivabradine on inflammatory pain in healthy volunteers
Acronym
Analgesic effects of Ivabradine on inflammatory pain
Scientific Title
Analgesic effects of Ivabradine on inflammatory pain in healthy volunteers
Scientific Title:Acronym
Analgesic effects of Ivabradine on inflammatory pain
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, on pathological pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of Ivabradine on spontaneous pain produced by Capsaicin
Key secondary outcomes
Effects of oral administration of Ivabradine on the thermal hyperalgesia, mechanical hyperalgesia, mechanical allodynia, and flare produced by topical application of Capsaicin
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 (5-15 mg) for 2 days
Interventions/Control_2
Oral administration of Placebo for 2 days
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults volunteers
Key exclusion criteria
chronic pain
history of heart failure
electrocardiogram abnormality
pregnant female
regular use of analgesics
neurologic deficits
psychotic and depressive disorder
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
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 | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
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
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
Institutional review board
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026532
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026532
Number of participants that the trial has enrolled
20
Results
A total of 20 healthy subjects were enrolled in this study (10 ivabradine first, 10 placebo first).
Primary outcome
Ivabradine (a HCN channel blocker), orally administered three times in two days, did not affect capsaicin-induced spontaneous pain compared to placebo.
Secondary outcomes
Ivabradine did not affect heat pain threshold in the primary zone, area of flare, and area of secondary mechanical hyperalgesia. In contrast, ivabradine reduced area of secondary mechanical allodynia compared to placebo.
Results date posted
| 2022 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Health subjects
Age (years) 25
Male sex, n (%) 18 (90)
Height (cm) 172
Weight (kg) 63
BMI (kg/m2) 22
Data are expressed as median unless otherwise indicated. BMI, body mass index.
Participant flow
Written informed consent was obtained from all participants after the study procedures and possible adverse effects were explained. Subjects were randomly assigned to the ivabradine-first group or placebo-first group. Each subject participated in 2 sessions separated by a washout period of greater than 7 days.
Adverse events
No adverse effects were observed in this study.
Outcome measures
Primary outcome: capsaicin-induced spontaneous pain
Secondary outcomes: heat pain threshold, flare size, area of secondary hyperalgesia, and area of secondary mechanical allodynia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 01 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026532
