Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment (EFO)

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: kondrium; Drug: kondrium f; Drug: methyl prednisolone (corticosteroid)

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Queretaro, Mexico
    • Hospital San José

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kondrium; intraarticular injections once month	Drug: kondrium; intraarticular injections once month
Experimental: kondrium f	Drug: kondrium f; intraarticular injections once month
Active Comparator: corticosteroid; intraarticular injections once month	Drug: methyl prednisolone (corticosteroid); intraarticular injections once month; Other Names: corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Nucitec
• Collaborators: National Council of Science and Technology, Mexico
• Investigators: Principal Investigator: Ricardo Amador, PhD, Hospital San José

Publications and helpful links

General Publications

• Caamano MDC, Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Rosado JL. A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Feb 16;10:1179544116688899. doi: 10.1177/1179544116688899. eCollection 2017.
• Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Caamano Mdel C, Rosado JL. Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial. BMC Musculoskelet Disord. 2015 May 13;16:114. doi: 10.1186/s12891-015-0568-4. Erratum In: BMC Musculoskelet Disord. 2015;16:256.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: osteoarthritis; knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: PEE-002-2007