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Recruitment status Completed
Unique ID issued by UMIN UMIN000006213
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email nonaka_taka@yahoo.co.jp

Sponsor
Institute Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007352


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