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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045700
Receipt No. R000052163
Scientific Title QOL questionnaire survey for nausea and vomiting under iron preparation in patients with menorrhagia or suffering anemia during menstruation
Date of disclosure of the study information 2021/10/11
Last modified on 2021/10/08

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Basic information
Public title QOL questionnaire survey for nausea and vomiting under iron preparation in patients with menorrhagia or suffering
anemia during menstruation
Acronym Survey of nausea and vomiting by iron preparation
Scientific Title QOL questionnaire survey for nausea and vomiting under iron preparation in patients with menorrhagia or suffering
anemia during menstruation
Scientific Title:Acronym Survey of nausea and vomiting by iron preparation
Region
Japan

Condition
Condition patients with menorrhagia or suffering anemia during menstruation who are taking iron preparation
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 QOL estimated formula construction for nausea and vomiting under iron preparation in patients with menorrhagia or suffering anemia during menstruation
Basic objectives2 Others
Basic objectives -Others Patients reported outcome through QOL questionnaire survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes QOL (EQ-5D 5L, VAS) for nausea and vomiting under iron preparation in patients with menorrhagia or suffering anemia during menstruation
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

Not applicable
Gender Female
Key inclusion criteria (1) patients with menorrhagia or suffering anemia during menstruation
(2) patients who have been taken iron preparation within 3 months
(3) over 20 years old
(4) patients who can access to internet through devices (PC, Tablet, Smartphone), and can use the devices by themselves or supporters
Key exclusion criteria (1) Patients who disagree with participating this survey
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Mikio
Middle name Momoeda
Last name Momoeda
Organization St. Luke's International Hospital
Division name Dept of Integrated Women's Health
Zip code 104-8560
Address 9-1 Akashicho Chuo-ku, Tokyo
TEL 03-3541-5151
Email momoedam@gmail.com

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Ito
Organization Torii Pharmaceutical Co., Ltd.
Division name Medical Affairs Dept,
Zip code 103-0023
Address 3-4-1, Nihonbashi-honcho, Chuo-ku, Tokyo
TEL 03-3231-6811
Homepage URL
Email kyoko.ito@torii.co.jp

Sponsor
Institute Crecon Medical Assessment Inc.
Institute
Department

Funding Source
Organization Torii Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization MINS
Address 5-20-9-401 Mita, Minato-ku, Tokyo
Tel 03-6416-1868
Email kyoko.ito@torii.co.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
2021 Year 10 Month 11 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
2021 Year 09 Month 15 Day
Date of IRB
2021 Year 09 Month 15 Day
Anticipated trial start date
2021 Year 10 Month 15 Day
Last follow-up date
2021 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participants who meet the inclusion criteria are recruited from Patient Panels. Patients reported outcome through QOL questionnaire survey will be used.

Management information
Registered date
2021 Year 10 Month 08 Day
Last modified on
2021 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052163

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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