Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial.

UMIN ID: C000000283

Registered date:15/11/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Knee Osteoarthritis
• Date of first enrollment: 2005/01/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patch group: external patch NSAIDs external patch were used on the tender spot around the knee joint 2 times (at morning, after bath or at night) per day. The external patch was kept at room temperature. The patients were able to stop their drugs when they no longer required treatment. NSAIDs were limited only one of the following three to prescribe; flurbiprofen, indometacin, and ketoprofen.
Oral agent group: Oral NSAIDs NSAIDs were limited only one of the following three to prescribe. These were the top three used in Japan at the present; loxoprofen sodium, diclofenac sodium, and zaltoprofen. They were also required to record exactly how many they had been taking medicine in a note.

Outcome(s)

• Primary Outcome: Functional assessment including ADL: JKOM Assessment of utility and safety.
• Secondary Outcome: Assessment of pain: VAS. Assessment of adverse event in the trial period.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day of agreement to enter the trial. (2) Patients who had done or planned operation against the knee within 6 months before or after the day of agreement to enter the trial. (3) Patients who require intraarticular injection. (4) Patients who require aspiration of joint fluid. (5) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs. (6) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis. (7) Patients who were diagnosed as rheumatoid arthritis, gout, pseudogout, or collagen diseases. (8) Patients who had some difficulty to fill up their treatment diary. (9) Patients with cardiac dysfunction. (10) Patients with liver dysfunction. (11) Patients with renal dysfunction. (12) Patients with peptic ulcer. (13)Patients who had a history of bronchial asthma (Aspirin asthma, etc). (14) Patients who had a history of Anaphylaxis for NSAIDs.

Related Information

• Primary Sponsor: The Japanese Society for Musculoskeletal Rehabilitation
• Secondary Sponsor: Japanese Clinical Orthopaedic Association
• Source(s) of Monetary Support: External Pharmaceutical Association