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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012229
Receipt No. 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

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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
Obsterics 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
Institute The University of Tokyo Hospital
Department of Obstetrics & Gynecology
Institute
Department

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
URL(English) https://upload.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


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