Status:
UNKNOWN
Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
SK Chemicals Co., Ltd.
Conditions:
Osteoarthritis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Osteoarthritis of the knee joint causes pain, stiffness, and restriction of joint movement in the knee joint due to degeneration of the knee cartilage. The purpose of osteoarthritis treatment is to im...
Detailed Description
The Investigators will conduct research to patients with outpatient treatment for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique that is general...
Eligibility Criteria
Inclusion
- Adults over 50
- Patients undergoing outpatient treatment in orthopedic surgery for osteoarthritis of the knee joint
- Patients diagnosed with Kellgren-Lawrence grade II or III osteoarthritis of the knee by imaging examination
- Patients with a pain VAS scale of 4 or more out of 10 with a pain in the knee joint during daily activities on flat ground
- Patients confirmed by the examiner for no abnormal results in blood tests, etc.
- Patients who are willing or able to follow doctor's instructions, including joint exercises
- Patients not participating in other clinical trials
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Exclusion
- Patients with secondary knee osteoarthritis
- Patients with hypersensitivity reactions and serious side effects to Celebrex or Joins
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients who underwent meniscus surgery on the knee joint in the painful area
- Patients who underwent total knee arthroplasty within 180 days of the knee joint opposite the pain area
- If there is construction or deformation of the knee joint in the pain area
- Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
- Hemoglobin A1c level \>8% of patients not managed by diabetes
- Patients with high blood pressure with poor blood pressure control (Systolic Blood Pressure of\> 150 mmHg or Diastolic Blood Pressure\> 95 mmHg)
- Patients taking PPI drugs for recurrent upper gastrointestinal ulcer or inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
- Patients with abnormal liver function (ALT)\> 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine\> 2.0 times ULN)
- Patients who took excessive narcotic analgesics for pain in the affected area before the clinical trial
- Patients scheduled for surgery during the clinical trial period
- Patients who received intraarticular injection treatment into the painful area of the knee within 3 months prior to the first visit
- Patients who received systemic steroid treatment within 3 months prior to their first visit
- Pregnant or lactating women
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04718649
Start Date
January 1 2021
End Date
December 1 2022
Last Update
January 22 2021
Active Locations (1)
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1
the Catholic Univerisity of Korea Seoul St Mary's hospital
Seoul, South Korea