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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041705
Receipt No. R000047583
Scientific Title A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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Basic information
Public title A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Acronym A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Scientific Title A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Scientific Title:Acronym A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Region
Japan

Condition
Condition gastrointestinal ulcer, reflux esophagitis, chronic constipation, ulcerative colitis , Crohn's disease, and hepatic cirrhosis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the impact of COVID-19 on the prescription, the disease condition, the quality of life and lifestyles of patients with gastrointestinal diseases.
Basic objectives2 Others
Basic objectives -Others To clarify the impact of COVID-19 on the prescription, the disease condition, the quality of life and lifestyles of patients with gastrointestinal diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The interval, amount, and days of prescriptions for medications of gastrointestinal diseases
Key secondary outcomes EQ-5D
J-HLS-EU-Q47
Adherence scale for patients with chronic disease

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
99 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients registered with Medilead Healthcare Panel (MHP) who have answers at the survey on December 2019 (past survey)
2. Patients who reported in- or outpatient visits for gastrointestinal diseases within 1 year before the past survey
3. Patients who reported gastrointestinal diseases (gastrointestinal ulcer, reflux esophagitis, chronic constipation, ulcerative colitis , Crohn's disease, and hepatic cirrhosis)
Key exclusion criteria 1. Patients who did not report any use of drugs for gastrointestinal diseases at the past survey
2. Patients who reported any cancer at the past survey
3. Patients who work for any of the following organizations
- market research companies
- media companies
- advertising companies
- hospitals or clinics
- pharmaceutical companies
- pharmaceutical wholesalers
4. Patients whose family members work for any of the above organizations
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hisanori
Middle name
Last name Masaki
Organization EA Pharma Co.,Ltd.
Division name Medical Division
Zip code 104-0042
Address Sumitomo-Irifune building, 2-1-1, Irifune, Chuo-Ku, Tokyo, JAPAN
TEL 03-6280-9500
Email hisanori_masaki@eapharma.co.jp

Public contact
Name of contact person
1st name Hisanori
Middle name
Last name Masaki
Organization EA Pharma Co.,Ltd.
Division name Medical Division
Zip code 104-0042
Address Sumitomo-Irifune building, 2-1-1, Irifune, Chuo-Ku, Tokyo, JAPAN
TEL 03-6280-9500
Homepage URL
Email hisanori_masaki@eapharma.co.jp

Sponsor
Institute EA Pharma Co.,Ltd.
Institute
Department

Funding Source
Organization EA Pharma Co.,Ltd.
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 Yamauchi clinic
Address 1-15-19, Jiyugaoka, Meguro-Ku, Tokyo, Japan
Tel 03-5575-5862
Email Not Appricable

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 09 Month 07 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 10 Day
Date of IRB
2020 Year 08 Month 20 Day
Anticipated trial start date
2020 Year 09 Month 07 Day
Last follow-up date
2020 Year 09 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A web-based survey on patients registered with Medilead Healthcare Panel (MHP) and meet all eligible criteria.

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047583

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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