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-

UMIN ID: UMIN000001026

Registered date:13/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Osteoarthrities
• Date of first enrollment: 2008/02/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Sodium hyaluronate : Suvenyl; intra-articular injection 25mg
Loxoprofen : Roxonin; tablet 60mg

Outcome(s)

• Primary Outcome: Change of JKOM score from baseline.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 80years-old
• Gender: Male and Female
• 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

• Primary Sponsor: Research Group of Cartilage Metabolism
• Source(s) of Monetary Support: none