Advertisement

Topics

Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

2014-08-27 03:19:19 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoarthritis

Intervention

kondrium, kondrium f, methyl prednisolone (corticosteroid)

Location

Hospital San Jose
Queretaro
Mexico

Status

Active, not recruiting

Source

Nucitec

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:19-0400

Clinical Trials [1077 Associated Clinical Trials listed on BioPortfolio]

Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to ...

Corticosteroid Reduction in COPD

This study explores whether using blood eosinophil guided treatment can reduce the accumulated dose prednisolone in patients with exacerbation of COPD.

Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

The purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined wit...

Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis

Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anes...

Prednisolone Addition for Patients With Recent-onset Psychotic Disorder

Treatment with prednisolone can be used as a proof of concept to investigate the possibility of immune modulation as a treatment for schizophrenia. It is expected that daily treatment with...

PubMed Articles [2321 Associated PubMed Articles listed on BioPortfolio]

Opposing effects of rheumatoid arthritis and low dose prednisolone on arginine metabolomics.

The effects of low dose prednisolone on circulating markers of endothelial function, the arginine metabolites asymmetric dimethyl arginine (ADMA), mono methyl arginine (MMA), and homoarginine, are unc...

Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid.

Recently, several studies suggested that radiofrequency (RF) ablation of the genicular nerves is a safe and effective therapeutic procedure for intractable pain associated with chronic knee osteoarthr...

Macrophage activation syndrome associated with systemic lupus erythematosus treated successfully with the combination of steroid pulse, immunoglobulin and tacrolimus.

Macrophage activation syndrome (MAS), a variant of secondary hemophagocytic lymphohistiocytosis, is a potentially life-threatening complication of inflammatory and autoimmune diseases. We present a ca...

Mycophenolate mofetil treatment in a patient with recurrent lymphocytic hypophysitis.

Lymphocytic hypophysitis (LHP) is a relatively rare disease characterised by lymphocytic infiltration of the pituitary gland, resulting in pituitary dysfunction. LHP is generally responsive to cortico...

Role of FKBP51 in the modulation of the expression of the corticosteroid receptors in bovine thymus following glucocorticoid administration.

The aim of this work was to study the transcriptional effects of glucocorticoids on corticosteroid hormone receptors, prereceptors (11β-hydroxysteroid dehydrogenase 1 and 2, 11β-HSD1 and 2), and cha...

Medical and Biotech [MESH] Definitions

A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.

A PREDNISOLONE derivative with similar anti-inflammatory action.

3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-4-methyl-5-(4,6,8,8-tetrahydroxy-3,5,7-trioxa-4,6,8-triphosphaoct-1-yl)thiazolium hydroxide, inner salt, P,P',P''-trioxide. The triphosphate ester of thiamine. In Leigh's disease, this compound is present in decreased amounts in the brain due to a metabolic block in its formation.

A nonfluorinated corticosteroid anti-inflammatory agent used topically for DERMATOSES.

3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.

More From BioPortfolio on "Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Arthritis
Arthritis is by definition the inflammation of one or more joints, characterized by swelling, pain, warmth, redness and diminished range of joint movement (Oxford Medical Dictionary). There are many different types; Noninflammatory; Osteoarthritis, N...

Pain
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...


Searches Linking to this Trial