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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030303
Receipt No. R000034518
Scientific Title Study on gastric emptying by measurement of 13 CO2 concentration during persistent expiration
Date of disclosure of the study information 2017/12/07
Last modified on 2020/12/09

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Basic information
Public title Study on gastric emptying by measurement of 13 CO2 concentration during persistent expiration
Acronym 13CO2 gastric emptying
Scientific Title Study on gastric emptying by measurement of 13 CO2 concentration during persistent expiration
Scientific Title:Acronym 13CO2 gastric emptying
Region
Japan

Condition
Condition functional dyspepsia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the pathophysiology of functional dyspepsia patients by objectively evaluating gastric emptying of functional dyspepsia patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes GEC,Tlag,T1/2
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 test meal Ensure H 250mL(375kcal)and 13C
sodium acetate 100mg
Interventions/Control_2
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 1) The sex does not matter in 20 years old or more
2) Functional dyspepsia and the patients who had a diagnosis
3) The previous history of treatment does not matter
4) It does not matter to inpatients, the outpatient
5) The patients that an agreement is obtained in a document about participation of this study
Key exclusion criteria 1) The patients that the wearing of the nasal cavity catheter for exclusive use of four hours is impossible
2) The patients who took in a diet and adipose many diets with the stimulant which is extreme overeating, alcohol consumption on the day before gastric emptying measurement
3) The patients (as for the moisture, possible until two hours ago) who were not able to follow that we did not take in a diet for six hours before gastric emptying measurement
4) The patients with a history of sensitivity to Ensure H
5) The patients with allergy to milk protein
6) The patients of the last years of nephrosis, renal failure
7) Heart failure patients who had nausea, vomiting, the diarrhea
8) In addition, the patients who were judged to be inadequate as subject by the judgment of the physici
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Shimoyama
Organization Gunma University Hospital
Division name gastroenterology and hepatology
Zip code 371-8511
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8137
Email yshimoyama@gunma-u.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Shimoyama
Organization Gunma University Hospital
Division name gastroenterology and hepatology
Zip code 3718511
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8137
Homepage URL
Email yshimoyama@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of clinical investigation and research unit, Gunma University Hospital
Address -39-15 Showa-machi, Maebashi, Gunma, Japan
Tel 027-220-8740
Email gunmaciru-office@umin.ac.jp

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
2017 Year 12 Month 07 Day

Related information
URL releasing protocol No
Publication of results Unpublished

Result
URL related to results and publications No
Number of participants that the trial has enrolled 0
Results Research was discontinued on March 31, 2019 due to difficulty in case registration.
Results date posted
2020 Year 12 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics No participants
Participant flow No
Adverse events No
Outcome measures No
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2017 Year 11 Month 29 Day
Date of IRB
2017 Year 11 Month 29 Day
Anticipated trial start date
2017 Year 12 Month 08 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 07 Day
Last modified on
2020 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034518

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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