UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011945 |
|---|---|
| Receipt number | R000013948 |
| Scientific Title | Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2017/04/05 10:50:35 |
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Basic information
Public title
Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain
Acronym
Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain
Scientific Title
Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain
Scientific Title:Acronym
Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain
Region
| Japan | Asia(except Japan) |
Condition
Condition
the mandibular horizontal impacted wisdom tooth
Classification by specialty
| Anesthesiology | Operative medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this clinical trial was to evaluate the safety and efficacy of a sustained-release lidocaine sheet for the pain in a patient after tooth extraction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
VAS, pain-killer rescue postoperatively and patient satisfaction are compared with those of controled group.
Key secondary outcomes
VAS, pain-killer rescue postoperatively and patient satisfaction are compared with those of non-administration group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Non-administration
Interventions/Control_2
Pracebo-Control
Poly (Lactic-co-Glycolic Acid) 100mg
Interventions/Control_3
a sustained- release lidocaine sheet (SRLS) 100mg
Interventions/Control_4
the SRLS 200mg (100mg*2)
Interventions/Control_5
the SRLS 400mg (100mg*4)
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Elective operation
2)ASA-PS 1, 2
3)Extraction of the mandibular horizontal impacted wisdom tooth
4)Obtaining an agreement of document about this study
Key exclusion criteria
1)A person taking a drug (e.g. antipsychotic, NSAIDs, and opioid) considered to participate in pain relief or judged that the influence is left even if canceled
2)A patient whose surgical site infects remarkably
3)A patient who has an allergy to Lidocaine, an amide type local anaesthetic agent, Celecoxib, a sulfonamide, Acetaminophen
4)A patient with a serious disturbance of conduction system (e.g. complete atrioventricular block)
5)A patient with peptic ulcer or asthma
6)A patient who has disturbance of consciousness or not able to communicate enough to evaluate correctly
7)A patient who is judged unsuitable for this trial by attending doctor
Target sample size
100
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
027-220-8454
toshis_free-hospital@yahoo.co.jp
Public contact
Name of contact person
| 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
027-220-8454
Homepage URL
toshis_free-hospital@yahoo.co.jp
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
Department of Anesthesiology and Intensive Care, Padjadjaran University
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）
Hasan Sadikin Hospital/Medical Faculty, Padjadjaran University (Bandung, Indonesia)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 02 | Day |
Last modified on
| 2017 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013948
