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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041960
Receipt No. R000047818
Scientific Title Long-term safety study of Posterisan forte ointment in patients with hemorrhoid
Date of disclosure of the study information 2020/10/01
Last modified on 2020/10/01

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Basic information
Public title Long-term safety study of Posterisan forte ointment in patients with hemorrhoid
Acronym Long-term safety study of Posterisan forte ointment in patients with hemorrhoid
Scientific Title Long-term safety study of Posterisan forte ointment in patients with hemorrhoid
Scientific Title:Acronym Long-term safety study of Posterisan forte ointment in patients with hemorrhoid
Region
Japan

Condition
Condition hemorrhoid
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate long-term safety of Posterisan forte ointment
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of drug-related adverse events
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria First visit patients from June to December in 2019, diagnosed with hemorrhoid and prescribed with Posterisan forte ointoment
Key exclusion criteria Patients with anal surgery during observation
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Shota
Middle name
Last name Takano
Organization Coloproctologycenter Takano Hospital
Division name Department of proctology
Zip code 8620971
Address 3-2-55, Oe, Chuo-ku, Kumamoto
TEL 0963206500
Email mic@takano-hospital.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Udo
Organization Coloproctologycenter Takano Hospital
Division name Medical Information Center
Zip code 8620971
Address 3-2-55, Oe, Chuo-ku, Kumamoto
TEL 0963206500
Homepage URL
Email mic@takano-hospital.jp

Sponsor
Institute Coloproctologycenter Takano Hospital
Institute
Department

Funding Source
Organization Maruho Co., Ltd
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 Coloproctologycenter Takano Hospital Ethical Review Board
Address 3-2-55, Oe, Chuo-ku, Kumamoto
Tel 0963206500
Email mic@takano-hospital.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 10 Month 01 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 08 Month 06 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study

Management information
Registered date
2020 Year 10 Month 01 Day
Last modified on
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047818

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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