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Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

NCT00977444 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2010-01-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

kondrium

intraarticular injections once month

DRUG

kondrium f

intraarticular injections once month

DRUG

methyl prednisolone (corticosteroid)

intraarticular injections once month

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Nucitec

    lead INDUSTRY

Principal Investigators

  • Ricardo Amador, PhD · Hospital San Jose

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-02-28
Completion
2009-10-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977444 on ClinicalTrials.gov