UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041960 |
|---|---|
| Receipt number | 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 08:37:11 |
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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
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
mic@takano-hospital.jp
Sponsor or person
Institute
Coloproctologycenter Takano Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047818
