Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
This trial is active, not recruiting.
|Treatments||kondrium, kondrium f, methyl prednisolone (corticosteroid)|
|Phase||phase 2/phase 3|
|Collaborator||National Council of Science and Technology, Mexico|
|Start date||November 2007|
|End date||February 2009|
|Trial size||114 participants|
|Trial identifier||NCT00977444, PEE-002-2007|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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.
time frame: 4 months
Male or female participants at least 40 years old.
- 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
- 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
|Official title||Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment|
|Principal investigator||Ricardo Amador, PhD|
|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.|
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