UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015601 |
|---|---|
| Receipt number | 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 11:13:52 |
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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
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
m1164972@med.osaka-cu.ac.jp
Sponsor or person
Institute
Deaprtment of Gastroenterology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018123
