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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008260
Receipt No. R000009735
Scientific Title Open-label, randomized parallel group trial on the efficacy and safety of intra-articular administration of bevacizumab for knee osteoarthritis.
Date of disclosure of the study information 2012/07/01
Last modified on 2012/06/26

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Basic information
Public title Open-label, randomized parallel group trial on the efficacy and safety of intra-articular administration of bevacizumab for knee osteoarthritis.
Acronym Trial for the efficacy and safety of bevacizumab for knee osteoarthritis.
Scientific Title Open-label, randomized parallel group trial on the efficacy and safety of intra-articular administration of bevacizumab for knee osteoarthritis.
Scientific Title:Acronym Trial for the efficacy and safety of bevacizumab for knee osteoarthritis.
Region
Japan

Condition
Condition Osteoarthritis of knee joints
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate therapeutic effects and safety of intra-articular administration of bevacizumab for symptomatic knee osteoarthritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the symptoms before and after the administration of bevacizumab.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intra-articular administration of bevacizumab
Interventions/Control_2 Intra-articular administration of sodium hyaluronate
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Primary knee osteoarthritis with significant symptoms.
2. Aged 50 years or older.
3. Obtainment of informed consent in writing.
Key exclusion criteria 1. Patients who do not have any significant physical, neurological, or mental problems.
2. Patients who do not have any significant disorders in motor systems.
3. Patients who are inadequate to enter the trial by physicians' judgments
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoshi Fukui
Organization National Hospital Organization Sagamihara Hospital
Division name Department of Orthopaedic Surgery and Clinical Research Center
Zip code
Address Sakuradai 18-1, Minami-ku, Sagamihara, Kanagawa 252-0315, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Hospital Organization Sagamihara Hospital
Division name Department of Orthopaedic Surgery and Clinical Research Center
Zip code
Address Sakuradai 18-1, Minami-ku, Sagamihara, Kanagawa 252-0315, Japan
TEL
Homepage URL
Email n-fukui@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara Hospital
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2012 Year 07 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 Open public recruiting
Date of protocol fixation
2012 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 06 Month 26 Day
Last modified on
2012 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009735

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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