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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015601
Receipt No. R000018123
Scientific Title Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer
Date of disclosure of the study information 2014/11/07
Last modified on 2015/12/17

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Basic information
Public title Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer
Acronym Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer
Scientific Title Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer
Scientific Title:Acronym Effect of ONO-8539 on Transient Lower Esophageal Sphincter Relaxation in healthy male volunteer
Region
Japan

Condition
Condition gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we examined the effect of ONO-8539 on the number of TLESRs by using high resolution manometry(HRM).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of TLESRs
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ONO-8539 450mg after breakfast, wash out over 1 week, placebo after breakfast
Interventions/Control_2 placebo after breakfast, wash out over 1 week, ONO-8539 450mg after breakfast
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
65 years-old >
Gender Male
Key inclusion criteria 1. Healthy adults
2. Subjects who don't have a trouble with the insertion of a transnasal endoscope at screening or within 3 months before this study
3. Subjects with written informed consent
4. non-smoker
Key exclusion criteria 1. Subjects who take drugs except for nasal spray within 1 week befor intervention
2. Subjects whose basal LES pressure is less than 5mmHg at HRM
3. Subjects who drink alcohol or take nicotine within 24 hours before intervention
4. Subjects who are enrolled in other clinical trials within 3 months before this study
5. Past history of GI tract surgery except for endoscopic treatment
6. Any liver, kidney, or heart diseases
7. Subjects who are not eligible for participation judged by a doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Fujiwara
Organization Osaka City University Graduate School of Medicine
Division name Deaprtment of Gastroenterology,
Zip code
Address 1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL 06-6645-3811
Email yasu@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akinari Sawada
Organization Osaka City University Graduate School of Medicine
Division name Deaprtment of Gastroenterology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku,Osaka 545- 8585, Japan
TEL 06-6645-3811
Homepage URL
Email m1164972@med.osaka-cu.ac.jp

Sponsor
Institute Deaprtment of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 07 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
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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 07 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 04 Day
Last modified on
2015 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018123

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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