UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1/2 clinical trial of a sustained- release lidocaine sheet for postoperative pain
Title of the study (Brief title)	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	Toshiyuki SUZUKI
Organization	Gunma University Hospital
Division name	Department Of Anesthesiology
Address	3-39-15 Showa-machi, Maebashi-shi Gunma371-8511, Japan
TEL	027-220-8454
Email	toshis_free-hospital@yahoo.co.jp

Public contact
Name of contact person	Toshiyuki SUZUKI
Organization	Gunma University Hospital
Division name	Department Of Anesthesiology
Address	3-39-15 Showa-machi, Maebashi-shi Gunma371-8511, Japan
TEL	027-220-8454
Homepage URL
Email	toshis_free-hospital@yahoo.co.jp

Sponsor
Institute	Department Of Anesthesiology Gunma University graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013948