Osteoarthritis
Conditions
Keywords
knee, osteoarthritis
Brief summary
Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
Detailed description
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score. The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.
Interventions
DRUGkondrium
intraarticular injections once month
DRUGkondrium f
intraarticular injections once month
DRUGmethyl prednisolone (corticosteroid)
intraarticular injections once month
Sponsors
National Council of Science and Technology, Mexico
Nucitec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 40 years * symptomatic evidence of OA in the knee for at least 1 year * radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee * no intra-articular injection of corticosteroids within the last 3 months
Exclusion criteria
* any history of adverse reaction to the study drugs * current pregnancy status * uncontrolled hypertension * active infection * undergone surgery/arthroscopy within three months * diagnosis of radiographic OA of Kellgren and Lawrence grade I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index. | 4 months |
Countries
Mexico
Outcome results
None listed