UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004248
Receipt No. R000005102
Scientific Title A clinical trial of differential nerve block with lidocaine derivatives in healthy human volunteers
Date of disclosure of the study information 2010/10/01
Last modified on 2014/06/07

* 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 A clinical trial of differential nerve block with lidocaine derivatives in healthy human volunteers
Acronym Differential nerve block with lidocaine derivatives
Scientific Title A clinical trial of differential nerve block with lidocaine derivatives in healthy human volunteers
Scientific Title:Acronym Differential nerve block with lidocaine derivatives
Region
Japan

Condition
Condition regional anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the potentials for differential nerve block with lidocaine derivative sodium channel blockers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes For evaluating if lidocaine derivatives tested in this trial can produce differential block, mechanical, thermal, cold, and touch sensation are assessed
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 6
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lidocain derivatives and capsaicin are injected subcutaneously into the forearm of healthy human volunteers
Interventions/Control_2 Physiological saline and capsaicin are injected subcutaneously into the forearm of healthy human volunteers
Interventions/Control_3 Thermal stimulation (45 degree) is applied on the site where lidocaine derivatives have been injected
Interventions/Control_4 Thermal stimulation (45 degree) is applied on the site where physiological saline has been injected
Interventions/Control_5 Tiny incision on the site where lidocaine derivatives have been injected
Interventions/Control_6 Tiny incision on the site where physiological saline has been injected
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria healthy human volunteer
Key exclusion criteria except above
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiyuki Sakamoto
Organization Shinshu Univ. school of medicine
Division name Dept. anesthesiology and resuscitology
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263352734
Email akiyuki@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakamoto Akiyuki
Organization Shinshu Univ. school of medicine
Division name Dept. anesthesiology and resuscitology
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263352734
Homepage URL
Email akiyuki@shinshu-u.ac.jp

Sponsor
Institute Dept. anesthesiology and resuscitology, Shinshu Univ. school of medicine
Institute
Department

Funding Source
Organization none
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
Email

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
2010 Year 10 Month 01 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
2010 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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
2010 Year 09 Month 22 Day
Last modified on
2014 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.