UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006213 |
|---|---|
| Receipt number | R000007352 |
| Scientific Title | Effect of sitagliptin on the rate of gastric emptying |
| Date of disclosure of the study information | 2011/08/23 |
| Last modified on | 2014/01/24 16:09:00 |
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Basic information
Public title
Effect of sitagliptin on the rate of gastric emptying
Acronym
Effect of sitagliptin on the rate of gastric emptying
Scientific Title
Effect of sitagliptin on the rate of gastric emptying
Scientific Title:Acronym
Effect of sitagliptin on the rate of gastric emptying
Region
| Japan |
Condition
Condition
Diabetes mellitus
Diabetic gastroparesis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sitagliptin, known as a DPP-4 inhibitor, protects the endogenous incretin hormones (both GLP-1 and GIP ) from degradation. Incretin hormones, especially GLP-1, inhibits gastric emptying. However, the pharmacological effects of sitagliptin on the rate of gastric emptying have not yet been sufficiently investigated.
The aim of this study is to examine the effect of sitagliptin on the rate of gastric emptying in healthy volunteers using a 13C breath test.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measuring of the rate of gastric emptying using a 13C breath test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin 50mg single oral administration with 50ml water
Interventions/Control_2
50ml water alone, no medication (i.e. control)
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 and Female
Key inclusion criteria
Subject who fills everything the following
1) Healthy volunteers of 20 years or more
2) Subject who gives written informed consent
Key exclusion criteria
The subject who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Subject who took medicine that influences movement and function of digestive tract such as prokinetics, gastric acid suppressants, NSAIDs and erythromycin within 4 weeks
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Maeda |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
nonaka_taka@yahoo.co.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, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
nonaka_taka@yahoo.co.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
横浜市立大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 23 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 22 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007352
