Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

Osteoarthritis Clinical Trial

— EFO  

Official title:

Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00977444
• Other study ID #: PEE-002-2007
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 11, 2009
• Last updated: January 19, 2010
• Start date: November 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: Nucitec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: October 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis

Intervention

Drug:
• kondrium
intraarticular injections once month
• kondrium f
intraarticular injections once month
• methyl prednisolone (corticosteroid)
intraarticular injections once month

Locations

Country	Name	City	State
Mexico	Hospital San Jose	Queretaro

Sponsors (2)

Lead Sponsor	Collaborator
Nucitec	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes