UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022200 |
|---|---|
| Receipt number | R000025574 |
| Scientific Title | Impact of lubiprostone on gastric emptying in healthy volunteer |
| Date of disclosure of the study information | 2016/05/06 |
| Last modified on | 2018/11/05 20:09:07 |
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Basic information
Public title
Impact of lubiprostone on gastric emptying in healthy volunteer
Acronym
Impact of lubiprostone on gastric emptying in healthy volunteer
Scientific Title
Impact of lubiprostone on gastric emptying in healthy volunteer
Scientific Title:Acronym
Impact of lubiprostone on gastric emptying in healthy volunteer
Region
| Japan |
Condition
Condition
gastric emptying
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of lubiprostone on gastric emptying in healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of gastric emptying parameters after administration of lubiprostone
Key secondary outcomes
Gastrointestinal symptom
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
single dose of lubiprostone 24 microgram 1 tablet
Interventions/Control_2
single dose of lubiprostone 24 microgram 1 tablet and domperidone 10 mirigram 1 tablet
Interventions/Control_3
no medication
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
who has neither gastrointestinal symptoms, medications taken regularly, nor past history of abdominal surgery.
Key exclusion criteria
who does not match the above condition.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatsugu Yamamoto |
Organization
Teikyo University
Division name
Internal Medicine
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
ymmt@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatsugu Yamamoto |
Organization
Teikyo University
Division name
Internal Medicine
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
ymmt@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2016 | Year | 05 | Month | 06 | 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
| 2016 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 04 | Day |
Last modified on
| 2018 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025574
