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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039334
Receipt No. R000044741
Scientific Title A single center cross-sectional study on evaluation of gastric hypersensitivity by measuring gastric pressure and CO2 injection volume under endoscopy
Date of disclosure of the study information 2020/02/03
Last modified on 2020/01/31

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Basic information
Public title A single center cross-sectional study on evaluation of gastric hypersensitivity by gastric function test
Acronym A single center cross-sectional study on evaluation of gastric hypersensitivity
Scientific Title A single center cross-sectional study on evaluation of gastric hypersensitivity by measuring gastric pressure and CO2 injection volume under endoscopy
Scientific Title:Acronym Parallel-group comparative study on evaluation of gastric hypersensitivity
Region
Japan

Condition
Condition Drug-registant functional dyspepsia(FD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the validity of gastric hypersensitivity evaluation by measuring gastric pressure and CO2 injection volume under endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Difference of gastric pressure and CO2 injection volume between drug-resistant FD patients and non-FD patients when their symptoms appear
2. Gastric pressure, cut-off value of CO2 injection volume, sensitivity and specificity of drug-resistant FD patients
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Age: Over 20 years old and younger than 80 years old
2. Gender: Both males and females
3. Outpatient
4. Patients who have been diagnosed with FD and their symptoms have not improved by drug therapy
(PPI, prokinetics)
5. Patients who understood study, and provided written consent based on their own will
Key exclusion criteria 1. Patients with malignancy
2. Patients with suspected with active infection
3. Pregnant or possibility of being pregnant, and those who are breath feeding
4. Study participation decided to be contraindicated by the
parson in charge
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Katsuhiko
Middle name
Last name Iwakiri
Organization Nippon Medical School
Division name Department of Gastroenterology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email k-iwa@nms.ac.jp

Public contact
Name of contact person
1st name Eri
Middle name
Last name Momma
Organization Nippon Medical School
Division name Department of Gastroenterology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email eri-momma@nms.ac.jp

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

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 Nippon Medical School Hospital
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel 03-3822-2131
Email eri-momma@nms.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
2020 Year 02 Month 03 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
2018 Year 02 Month 23 Day
Anticipated trial start date
2018 Year 03 Month 20 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigated whether this system of measuring CO2 injection volume and gastric pressure is useful for evaluating gastric hypersensitivity in drug-resistant FD patients who are strongly suspected to have gastric hypersensitivity.

Management information
Registered date
2020 Year 01 Month 31 Day
Last modified on
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044741

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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