UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mizollibin Therapy for Pigmented Villonodular Synovitis or Giant cell tumor of tendon sheath
Title of the study (Brief title)	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	Masahiko Suzuki
Organization	Graduate School of Medicine, Chiba University
Division name	Orthopaedic Surgery
Address	1-8-1 Inoha Chuo-ku Chiba
TEL	043-226-2117
Email	masahiko@faculty.chiba-u.jp

Public contact
Name of contact person	Masahiko Suzuki
Organization	Graduate School of Medicine, Chiba University
Division name	Orthopaedic Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004887