UMIN-CTR Clinical Trial

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

Osteoarthritis of the hip

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Orthopaedic Surgery, Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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

Date of disclosure of the study information

2015

Year

06

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

06

Month

22

Day

Last modified on

2016

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020857