The purpose of this study is to evaluate the pain relief effect of Co-administration of Diacerein with Celecoxib in patients with knee osteoarthritis compared with single administration of each drug.
A large epidemiological study in Europe reported that over four-thirds of patients with osteoarthritis received combination therapy with two or more drugs. Approximately 1.5% of patients with osteoarthritis using three or more drugs are using COX-2(Cyclo-oxygenase-2) inhibitors and SYSADOA(Symptomatic slow acting drug), And it has been investigated that much more patients are using the two classes of drugs when the range is extended to other oral NSAIDs other than COX-2 inhibitors. Therefore, considering the characteristics of patients with osteoarthritis, such as basal disease and treatment effects on each type of drug, it is important to find the optimal combination of drugs for each patient characteristics. There is a previous study using osteoarthritis rat model as a biological basis of diacerein and celecoxib administration. Previous studies have shown that the combined use of Diacerein and Celecoxib improves osteoarthritis. The purpose of this study is to evaluate the pain relief effect of Co-administration of Diacerein with Celecoxib in patients with knee osteoarthritis compared with single administration of each drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Seoul ST. Mary's Hospital
Seoul, South Korea
RECRUITINGKorea University Guro Hospital
Seoul, South Korea
RECRUITINGpain VAS score
Changes in pain VAS(Visual analogue scale) score before and after 12 weeks of drugs administration. (No pain score: 0, Worst pain score: 100)
Time frame: 12 weeks after randomization
pain NRS score
Changes in pain NRS(Numeric rating scale) score before and after 12 weeks of drugs administration. (No pain score: 0, Worst pain score: 10)
Time frame: 12 weeks after randomization
WOMAC index score
Changes in WOMAC(Western Ontario and mcmaster Universities Osteoarthritis Index) index score before and after 12 weeks of drugs administration (possible score range, Pain: 0-20, Stiffness: 0-8, Physical function: 0-68; Total Score range: 0-96 ('none' to 'extreme'))
Time frame: 12 weeks after randomization
GSRS index score
Changes in GSRS(Gastrointestinal symptom rating scale) index score before and after 12 weeks of drugs administration. (Score range: 0-45 ('none' to 'extreme'))
Time frame: 12 weeks after randomization
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