NIPH Clinical Trials Search

UMIN ID: C000000283

Registered date:15/11/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedKnee Osteoarthritis
Date of first enrollment2005/01/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
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.


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

Key inclusion & exclusion criteria

Age minimum50years-old
Age maximum80years-old
GenderMale and Female
Include criteria
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


public contact
Name Tsutomu Iwaya
Address Namiki 4-1, Tokorozawa, Saitama Japan
Telephone 04-2995-3100(2010)
Affiliation National Rehabilitation Center for Persons with Disabilities Director,Training Center
scientific contact
Name Tsutomu Iwaya
Address Yakusiji 3311-1, Minami-Kawachimachi, Tochigi Japan
Telephone 0285-58-7374
Affiliation Chief Director, The Japanese Society for Musculoskeletal Rehabilitation The Japanese Society for Musculoskeletal Rehabilitation, c/o Department of Orthopaedic Surgery, Jichi Medical School