UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008248 |
|---|---|
| Receipt number | R000009725 |
| Scientific Title | Phase 1 clinical trial of slow-release lidocaine sheet on normal mucous membrane |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2013/03/05 09:56:16 |
* 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
Phase 1 clinical trial of slow-release lidocaine sheet on normal mucous membrane
Acronym
Phase 1 clinical trial of slow-release lidocaine sheet
Scientific Title
Phase 1 clinical trial of slow-release lidocaine sheet on normal mucous membrane
Scientific Title:Acronym
Phase 1 clinical trial of slow-release lidocaine sheet
Region
| Japan |
Condition
Condition
Healthy male subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Safety and efficacy of slow-release lidocaine sheet on normal mucous membrane in human
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Ascertaining adverse events and side effects
Key secondary outcomes
Examining analgesic effects and operative hours with the von frey test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
40% slow-release lidocaine 50mg
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1. A person who has a enough understanding and a consent to the trial
2. A person has no anatomical disorders and no diseases inside those nasal cavities
Key exclusion criteria
1. A person takes some medicine or remain an effect of stopped medicines
2. A person has an allergy to lidocaine and anesthetics kindred with lidocaine
3. A person has arrhythmia on ECG
4. A person is not conscious enough to evaluate correctly or not able to communicate
5. A person is judged unsuitable for the trial by a doctor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki SUZUKI |
Organization
Gunma University Hospital
Division name
Department Of Anesthesiology
Zip code
Address
3-39-15 Showa-machi, Maebashi-shi Gunma371-8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gunma University Hospital
Division name
Department Of Anesthesiology
Zip code
Address
3-39-15 Showa-machi, Maebashi-shi Gunma371-8511, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department Of Anesthesiology
Gunma University graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
群馬大学医学部附属病院（群馬県）
Gunma University Hospital (Gunma)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 25 | 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
Mean pain thresholds in a nasal mucous membrane applied the controlled release- lidocaine sheet on was significantly higher compared with preadministration for 72 hours
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
| 2012 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 29 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 29 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 28 | Day |
Other
Other related information
Target sample size has been changed in 24th OCT 2012
Management information
Registered date
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009725
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
