UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone, a prospective randomized controlled study
Title of the study (Brief title)	The efficacy of l-mentol for upper gastrointestinal endoscopy, with dimethicone versus without dimethicone
Region	Japan

Condition
Condition	Cases requiring upper gastrointestinal endoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of l-mentol with dimethicone and without dimethicone for upper gastrointestinal endoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination time
Key secondary outcomes	The presence or absence of bubble and the rate of side effects

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	The examination of upper gastrointestinal endoscopy underwent using l-mentol with 2% dimeticone
Interventions/Control_2	The examination of upper gastrointestinal endoscopy underwent that use l-mentol without 2% dimeticone
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases evaluated by upper gastrointestinal endoscopy.
Key exclusion criteria	The patient has allergy to l-mentol or 2% dimethicone. Cases with severe complications are excluded.
Target sample size	80

Research contact person
Name of lead principal investigator	Hattori Masashi
Organization	Medical corporation Yamashita Hospital
Division name	Gastroenterology
Address	1-3-5, Nakamachi, Ichinomiya
TEL	0586-45-4511
Email	m.hattori@yamashita.or.jp

Public contact
Name of contact person	Esaki Masaya
Organization	Medical corporation Yamashita Hospital
Division name	Gastroenterology
Address	1-3-5, Nakamachi, Ichinomiya
TEL	0586-45-4511
Homepage URL
Email	m.esaki@yamashita.or.jp

Sponsor
Institute	Medical corporation Yamashita Hospital
Institute
Department

Funding Source
Organization	Medical corporation Yamashita Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 07 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026402