NEXT STUDY

JRCT ID: jRCTs021180050

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: osteoarthritis of the knee
• Date of first enrollment: 20/12/2017
• Target sample size: 216
• Study type: Interventional

Intervention(s)

Study drug group: S-flurbiprofen plaster (SFPP) tape, 1 patch per day.
Control group: combination of oral and patch NSAIDs.

Outcome(s)

• Primary Outcome: The amount of change in Visual Analog Scale (VAS) after 4 weekes treatment.

Secondary Outcome

The amount of change in Visual Analog Scale (VAS) after 2 weekes treatment.
The amount of change in Knee Injury and Osteoarthritis Outcome Score (KOOS), JOA score and 2-step test after 2 and 4 weekes treatment.
The amount of change in Locomo 25 and EQ-5D after 4 weekes treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients with the knee to be evaluated at KL classification grade 2-3
2.Patients receiving no treatment for gonarthrosis to be evaluated within 14 days before starting the study (although treatment by taking medicine only when necessary will be allowed)
3.Patients with a standing VAS of 40 mm or higher at the knee to be evaluated when starting the study
4.Patients with no pain symptom on the other (non-evaluated) knee which would affect the evaluation
5.Patients who can receive and understand explanation on the study, and give a written consent by his/her own previously, upon participating the study

Exclude criteria

1.Patients who have received joint replacement or highly restricted range of motion (extension/flex) on the knee to be evaluated
2.Patients with other knee pain diseases, diseases impairing ADL, neuropsychiatric diseases, dementia, severe hypertension, peptic ulcer, serious diseases, or skin diseases
3.Patients with a history of dermatitis requiring treatment with patches;
4.Patients with a history of allergy to NSAIDs
5.Patients who have or have had aspirin asthma (asthma attack induced by NSAIDs, etc)
6.Women who are pregnant or possibly pregnant, nursing, or planning to be pregnant, or men who wish his partner to be pregnant, during the study period
7.Other patients applicable to contraindication according to the current product labelling of the study drug.

Related Information

• Primary Sponsor: Ishibashi Yasuyuki
• Source(s) of Monetary Support: Taisho Toyama Pharmaceutical Co., Ltd.,Teijin Pharma Ltd.
• Secondary ID(s): UMIN000029709