Unique ID issued by UMIN | UMIN000005730 |
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Receipt number | R000006777 |
Scientific Title | Examination of Efficacy and safety of Bepotastine besilate (TALION Tablets) for pruritic skin diseases in scar |
Date of disclosure of the study information | 2011/06/07 |
Last modified on | 2017/12/12 12:27:41 |
Examination of Efficacy and safety of Bepotastine besilate (TALION Tablets) for pruritic skin diseases in scar
Examination of Efficacy and safety of Bepotastine besilate (TALION Tablets) for pruritic skin diseases in scar
Examination of Efficacy and safety of Bepotastine besilate (TALION Tablets) for pruritic skin diseases in scar
Examination of Efficacy and safety of Bepotastine besilate (TALION Tablets) for pruritic skin diseases in scar
Japan |
pruritic skin diseases in scar
Plastic surgery |
Others
NO
To examine usefulness of bepotastine besilate against pruritus in skin scar which does not disappear by existing treatment
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Subjective sign and objective symptom
1)Subjective symptoms: itch, spontaneous pain, pain on pressure,sense of tumoral and evaluate the degree of the feeling in VAS(100mm)
2)Objective symptom : Skin symptom (color, wrinkle, luster, height, flare around the scar, expansion of the scar)
last total improvement , usefulness
Discontinuation rate by ineffectiveness
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Top the offered figure in the existing treatment group; and Bepotastine (eight weeks)
Existing treatment group (eight weeks)
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients who were pruritic skin diseases in scar
2) Patients who have pruritus which does not disappear by existing treatment cored VAS>=30
3)Patients who gave their written informed consent after explanation of the study
1)Patients who are renal dysfunction
2)Patients who are pregnant or might be pregnant
3)Patients who are considered unsuitable for this study by the investigator
60
1st name | |
Middle name | |
Last name | Hiroyuki Sakurai |
Tokyo Woman's Medical University
Plastic surgery
8-1 Kawada-cho Shinjuku-ku,Tokyo 162-8666,Japan
03-3353-8111
1st name | |
Middle name | |
Last name | Jiro Katahira |
Tokyo Woman's Medical University
Plastic surgery
8-1 Kawada-cho Shinjuku-ku,Tokyo 162-8666,Japan
03-3353-8111
Tokyo Woman's Medical University
Tokyo Woman's Medical University
Other
NO
2011 | Year | 06 | Month | 07 | Day |
Unpublished
Terminated
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 06 | Month | 01 | Day |
2011 | Year | 06 | Month | 07 | Day |
2017 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006777
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