This trial is active, not recruiting.

Condition osteoarthritis
Treatments kondrium, kondrium f, methyl prednisolone (corticosteroid)
Phase phase 2/phase 3
Sponsor Nucitec
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
intraarticular injections once month
kondrium kondrium
intraarticular injections once month
kondrium f kondrium f
intraarticular injections once month
(Active Comparator)
intraarticular injections once month
methyl prednisolone (corticosteroid) corticosteroid
intraarticular injections once month

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Nucitec.