Unique ID issued by UMIN | UMIN000012229 |
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Receipt number | R000014302 |
Scientific Title | The explorative clinical trial of a medicine for treatment of CIN (Cervical Intraepithelial Neoplasia) using lactobacillus to HPV16 positive CIN 2. |
Date of disclosure of the study information | 2013/12/01 |
Last modified on | 2017/12/07 10:47:45 |
The explorative clinical trial of a medicine for treatment of CIN (Cervical Intraepithelial Neoplasia) using lactobacillus to HPV16 positive CIN 2.
The explorative clinical trial of a medicine for treatment of CIN using lactobacillus to CIN2.
The explorative clinical trial of a medicine for treatment of CIN (Cervical Intraepithelial Neoplasia) using lactobacillus to HPV16 positive CIN 2.
The explorative clinical trial of a medicine for treatment of CIN using lactobacillus to CIN2.
Japan |
Cervical Intraepithelial Neoplasia 2 (CIN2)
Obstetrics and Gynecology |
Others
NO
It aims at the first drug therapy to CIN2 by inducing the mucosal cellular immunity to HPV oncoprotein E7 with the oral vaccine using lactobacillus.
Efficacy
Exploratory
Phase II
Clinical efficacy and safety
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
Central registration
2
Treatment
Medicine | Vaccine |
The CIN therapeutic vaccine or placebo will be taken in 20 days (1st~5th, 8th~12th, 22nd~26th and 50th~54th day) within all administering period (8 weeks). The dosage is assumed to be 4 capsules/time/a day.
The placebo will be taken in 20 days (1st~5th, 8th~12th, 22nd~26th and 50th~54th day) within all administering period (8 weeks). The dosage is assumed to be 4 capsules/time/a day.
20 | years-old | <= |
50 | years-old | > |
Female
1) HPV16 infected women
2) whom can observe all lesioned part by colposcopic inspection
3) patients were diagnosed with CIN2 histologically and judged that follow-up is necessary
4) whom of 20 ~ 50 years old when agreement is acquired.
5) outpatient
6) All patients were required to provide written informed consent.
1) Person who has obviously received prohibition of using together medicine (treatment) that causes person and immune suppression that has disease that abnormality is found in immune function
2) patients of SCC in cervical cytology.
3) whom hope for laser ablation or conization of the cervix
4) patients with serious acute illness
5) patients that there are previous histories of hypersensitivity in lactobacillus content food (yogurt etc.) and preparation of lactobacillus
6) patients who has allergy for milk
7) pregnant or expected to be pregnant
8) breast feeding mother
9) whom administered other trial drugs within three months before initiation of this trial study
10) whom administered this medicine
11) whom the investigator think inappropriate as a candidate.
40
1st name | |
Middle name | |
Last name | Kei Kawana |
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411(ext.33407)
kkawana-tky@umin.org
1st name | |
Middle name | |
Last name | Kei Kawana |
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411(ext.33407)
kkawana-tky@umin.org
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
MHLW
NO
東京大学医学部附属病院(東京都)
2013 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 30 | Day |
2013 | Year | 12 | Month | 10 | Day |
2013 | Year | 11 | Month | 07 | Day |
2017 | Year | 12 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014302
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