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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004056
Receipt No. R000004887
Scientific Title Mizollibin Therapy for Pigmented Villonodular Synovitis or Giant cell tumor of tendon sheath
Date of disclosure of the study information 2010/08/17
Last modified on 2016/08/22

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Basic information
Public title Mizollibin Therapy for Pigmented Villonodular Synovitis or Giant cell tumor of tendon sheath
Acronym MTPVNS
Scientific Title Mizollibin Therapy for Pigmented Villonodular Synovitis or Giant cell tumor of tendon sheath
Scientific Title:Acronym MTPVNS
Region
Japan

Condition
Condition Patients with pigmented villonodular synovitis or giant cell tumor of tendon sheath
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Does mizollibin clinically inhibit the infiltration of pigmented villonodular synovitis or giant cell tumor of tendon sheath?
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes to compare the extent of invasion in pigmented villonodular synovitis or giant cell tumor of tendon sheath roentgraphically between the start and end of the trial.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mizollibin 100mg-300mg/1 every day or every other day
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pigmented villonodular synovitis or giant cell tumor of tendon sheath
Key exclusion criteria Past history of mizollibin sensitivity
WBC count<3,000/mm3
Pregnant women
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Suzuki
Organization Graduate School of Medicine, Chiba University
Division name Orthopaedic Surgery
Zip code
Address 1-8-1 Inoha Chuo-ku Chiba
TEL 043-226-2117
Email masahiko@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Suzuki
Organization Graduate School of Medicine, Chiba University
Division name Orthopaedic Surgery
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba Chiba Japan
TEL 043-226-2117
Homepage URL
Email masahiko@faculty.chiba-u.jp

Sponsor
Institute Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 17 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 Open public recruiting
Date of protocol fixation
2010 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 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
2010 Year 08 Month 17 Day
Last modified on
2016 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004887

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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