UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012229
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

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Basic information

Public title

The explorative clinical trial of a medicine for treatment of CIN (Cervical Intraepithelial Neoplasia) using lactobacillus to HPV16 positive CIN 2.

Acronym

The explorative clinical trial of a medicine for treatment of CIN using lactobacillus to CIN2.

Scientific Title

The explorative clinical trial of a medicine for treatment of CIN (Cervical Intraepithelial Neoplasia) using lactobacillus to HPV16 positive CIN 2.

Scientific Title:Acronym

The explorative clinical trial of a medicine for treatment of CIN using lactobacillus to CIN2.

Region

Japan


Condition

Condition

Cervical Intraepithelial Neoplasia 2 (CIN2)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Clinical efficacy and safety

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Vaccine

Interventions/Control_1

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.

Interventions/Control_2

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.

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

20 years-old <=

Age-upper limit

50 years-old >

Gender

Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kei Kawana

Organization

The University of Tokyo Hospital

Division name

Department of Obstetrics & Gynecology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411(ext.33407)

Email

kkawana-tky@umin.org


Public contact

Name of contact person

1st name
Middle name
Last name Kei Kawana

Organization

The University of Tokyo Hospital

Division name

Department of Obstetrics & Gynecology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411(ext.33407)

Homepage URL


Email

kkawana-tky@umin.org


Sponsor or person

Institute

The University of Tokyo Hospital
Department of Obstetrics & Gynecology

Institute

Department

Personal name



Funding Source

Organization

MHLW

Organization

Division

Category of Funding Organization

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

東京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 12 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

Completed

Date of protocol fixation

2013 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 07 Day

Last modified on

2017 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014302


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name