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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018000
Receipt No. R000020857
Scientific Title Study on efficacy and safety of high molecular weight hyaluronic acid "Hylan G-F 20" for patients with osteoarthritis of the hip
Date of disclosure of the study information 2015/06/23
Last modified on 2016/06/22

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Basic information
Public title Study on efficacy and safety of high molecular weight hyaluronic acid "Hylan G-F 20" for patients with osteoarthritis of the hip
Acronym Efficacy and safety of Hylan G-F 20 injection for hip osteoarthritis
Scientific Title Study on efficacy and safety of high molecular weight hyaluronic acid "Hylan G-F 20" for patients with osteoarthritis of the hip
Scientific Title:Acronym Efficacy and safety of Hylan G-F 20 injection for hip osteoarthritis
Region
Japan

Condition
Condition Osteoarthritis of the hip
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and efficacy of intraarticular injection of hyaluronic acid for OA hips.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical findings and patient-based subjective assessment right after, 4, 8, and 12 weeks after intra-articular injection of hyaluronic acid
Key secondary outcomes Incidence of adverse events

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 Intraarticular injection of Hylan G-F 20 for osteoarthritis of the hip
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
20 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Patients meeting all following (1)-(4) at registration are adopted.
(1) Patients diagnosed OA of hip joint.
(2) Outpatients who can walk.
(3) Patients aged 20-84 years.
(4) Patients who submitted the consent of this study before the registration by understanding the method.

Key exclusion criteria Exclusion criteria of the patients are as follows.
(1) Patients lacking ability to agree or ability to express agreement for participation appropriately in this study.
(2) Pregnancy or its possibility.
(3) Patients suckling child.
(4) Patients with hypersensitivity for the ingredient of this medicine, hyaluronic acid, avian protein, feather, or egg.
(5) Patients with stagnation of venous blood or lymph fluid in lower limbs on injection side.
(6) Patients with a serious liver damage or its medical history.
(7) Patients with skin disease or with infection on the injection part.
(8) Patients with serious complications (heart disorder, renal disease, a malignant tumor, or compromised host such as immunodeficiency).
(9) Patients judged inadequate by the attending doctor.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Jinno
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-5-45 Yusshima, Bunkyo-ku, Tokyo
TEL 03-3813-6111
Email jinno.orth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gaku Koyano
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-3813-6111
Homepage URL
Email gaku@mtb.biglobe.ne.jp

Sponsor
Institute Department of Orthopaedic Surgery, Tokyo Medical and Dental University
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 YES
Study ID_1 24-08
Org. issuing International ID_1 Medical Hospital, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院(東京都)
Medical Hospital, Tokyo Medical and Dental University

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 23 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
2012 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 27 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2016 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020857

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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