NIPH Clinical Trials Search

UMIN ID: UMIN000001026

Registered date:13/02/2008

The effects of high molecular weight sodium hyaluronate on JKOM score and urine CTX-2 concentration -A randomized comparative clinical study with loxoprofen as a control drug-

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedOsteoarthrities
Date of first enrollment2008/02/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Sodium hyaluronate : Suvenyl; intra-articular injection 25mg Loxoprofen : Roxonin; tablet 60mg


Primary OutcomeChange of JKOM score from baseline.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum50years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria;Taken glucocorticoids (intra-articular injection, oral use, external use) within previous 4weeks ;Taken NSAIDs (oral, suppository, external) within previous 2weeks ;K-L grade of contralateral knee is 4 ;Secondary OA of the knee (eg. traumatic OA of the knee) ;Patellofemoral OA (K-L grade of more than 3) ;Moderate OA other than knee ;Rheumatoid arthritis ;Having history of total knee replacement or total hip replacement ;Having history of anaphylactoid reaction to sodium hyaluronan or loxoprofene ;Peptic ulcer ;Abnormal dysemia, abnormal hepatic function, abnormal kidney function, abnormal heart function ;Aspirin-induced asthma or its history ;.Inappropriate patients from the doctor's viewpoint

Related Information


public contact
Name Kunihiko Hayashi
Address Showamachi, Maebashi, Gunma 371-8514, Japan Japan
Telephone 027-220-8974
Affiliation central cordinating center Gunma univercity
scientific contact
Name Toshitaka Nakamura
Address address:1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555 Japan
Affiliation University of occupational and Environmental Health Orthopaedic Surgery.