UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010965 |
|---|---|
| Receipt number | R000012833 |
| Scientific Title | Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy |
| Date of disclosure of the study information | 2013/07/26 |
| Last modified on | 2018/06/18 12:42:41 |
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Basic information
Public title
Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Acronym
Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Scientific Title
Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Scientific Title:Acronym
Comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lubiprostone, a selective activator of type 2 chloride channels, is approved for treatment of chronic idiopathic constipation and recently constipation-predominant irritable bowel syndrome. It has been suggested that lubiprostone has a prokinetic effect.
We study that comparison of gastric and small-bowel transit time between Lubiprostone, and placebo-controlled in healthy volunteers : a double-blind, placebo-controlled study by capsule endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gastric and small-bowel transit time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
The group who takes Lubiprostone
Interventions/Control_2
The group who takes Placebo
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
| Not applicable |
Gender
Male
Key inclusion criteria
Patient who fills everything the following
1) Patient of 20 years or more
2) Patient who gives written informed consent
Key exclusion criteria
The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Subjects with malignancy
3)Others
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
inamorim@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama 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
| 2013 | Year | 07 | Month | 26 | 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
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012833
