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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011507
Receipt No. R000013464
Scientific Title The comparison of the effects on saliva secretion and gastric motility by between transnasal and transoral endoscopy
Date of disclosure of the study information 2013/08/18
Last modified on 2013/08/17

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Basic information
Public title The comparison of the effects on saliva secretion and gastric motility by between transnasal and transoral endoscopy
Acronym saliva trial
Scientific Title The comparison of the effects on saliva secretion and gastric motility by between transnasal and transoral endoscopy
Scientific Title:Acronym saliva trial
Region
Japan

Condition
Condition All diseases or symptoms those need upper gastrointestinal endoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By comparing the saliva secretion and gastric motility in transnasal and transoral endoscopy, to get the evidence that anticholinergic reagents are not necessary in transnasal upper gastrointestinal endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes saliva weight during the procedure
gastric motility (contraction times of pyloric ring and antrum per 1 minute)
Key secondary outcomes pain (by VAS scale and qestionnaire)
electrogastrogram

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 muscle injection of butylscoporamine bromide before the procedure by tranoral endoscopy
Interventions/Control_2 no muscle injection of butylscoporamine bromide before the procedure by tranoral endoscopy
Interventions/Control_3 no muscle injection of butylscoporamine bromide before the procedure by transnasal endoscopy
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

Not applicable
Gender Male and Female
Key inclusion criteria written informed consent
patients who need upper gastrointestinal endoscopy
patients who can be injected butylscoporamine bromide
Key exclusion criteria patients who have severe injury on important organs such as heart, blood, kidney and liver.
patients who have allergy against lidocain or butylscoporamine bromide
patients who have histories of abdominal surgery
patients not proper for butylscoporamine bromide injection such as prostate hypertrophy, glaucoma or arrythmia
patients who have bleeding tendency
patients who are thought to be not proper for the trial by the concerned doctors
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Matsushima
Organization Tokai University School of Medicine
Division name Dept of Int Med (gastroenterology)
Zip code
Address 143 Shimo-Kasuya, Isehara, Japan
TEL +81-463-93-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Matsushima
Organization Tokai University School of Medicine
Division name Dept of Int Med (gastroenterology)
Zip code
Address 143 Shimo-Kasuya, Isehara, Japan
TEL +81-463-93-1121
Homepage URL
Email mmatsush@is.icc.u-tokai.ac.jp

Sponsor
Institute Dept of Int Med (gastroenterology), Tokai University School of Medicine
Institute
Department

Funding Source
Organization The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 東海大学医学部付属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results 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
2008 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 10 Day
Last follow-up date
2011 Year 03 Month 31 Day
Date of closure to data entry
2012 Year 03 Month 31 Day
Date trial data considered complete
2012 Year 03 Month 31 Day
Date analysis concluded
2012 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 17 Day
Last modified on
2013 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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