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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006695
Receipt No. R000007910
Scientific Title Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Date of disclosure of the study information 2011/11/15
Last modified on 2014/12/09

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Basic information
Public title Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Acronym Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Scientific Title Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Scientific Title:Acronym Preventive effect of tranilast in early postoperative period on keloid and hypertrophic scar after surgery.
Region
Japan

Condition
Condition Keloid and Hypertrophic Scar
Classification by specialty
Surgery in general Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate preventive effect of tranilast administration from early postoperative period on keloid and hypertrophic scar after surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of Keloid and Hypertrophic Scar
Key secondary outcomes Symptom

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 tranilast
Interventions/Control_2 control : No treatment
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 Female
Key inclusion criteria Patients who undergo Obstetrics and gynecology surgery
Key exclusion criteria Keloid and Hypertrophic Scar
Pregnant women and women suspected of being pregnant
Patients with a history of hypersensitivity to any of the
ingredients of tranilast.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mamiko Tosa
Organization Nippon Medical School Musashi Kosugi Hospital
Division name Division of Plastic and Reconstructive Surgery
Zip code
Address 1-396 Kosugi-cho,nakahara-ku,kawasaki,kanagawa ,Japan
TEL 044-733-5181
Email tosa-m@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fusae Yoshida
Organization Nippon Medical School Musashi Kosugi Hospital
Division name IRB
Zip code
Address 1-396 Kosugi-cho,nakahara-ku,kawasaki,kanagawa ,Japan
TEL 044-733-5181
Homepage URL
Email fl-0351@nms.ac.jp

Sponsor
Institute Division of Plastic and Reconstructive Surgery, Nippon Medical School Musashi Kosugi 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
Address
Tel
Email

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 日本医科大学武蔵小杉病院
Nippon Medical School Musashi Kosugi Hospital

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 15 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 Completed
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2014 Year 12 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 09 Day
Last modified on
2014 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007910

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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