Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee - Full Text View

Sponsored by:	Eurofarma Laboratorios Ltda
Information provided by:	Eurofarma Laboratorios Ltda
ClinicalTrials.gov Identifier:	NCT00955552

Purpose

The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: Glucosamine sulphate and chondroitin sulphate association Drug: Condroflex (Zodiac)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-center, Randomized, Double Blind, Comparative of Efficacy and Safety From Association of Capsules Glucosamine and Chondroitin Sulfate (Eurofarma) Versus Condroflex (Zodiac) to Patients Treatment With Osteoarthrosis of the Knee Study

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Glucosamine hydrochloride Translagen Glucosamine sulfate Glucosamine Chondroitin Chondroitin sulfates

U.S. FDA Resources

Further study details as provided by Eurofarma Laboratorios Ltda:

Primary Outcome Measures:

To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Condroflex® (Zodiac) in same presentation and pharmaceutical form [ Time Frame: approximately 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	November 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Condroflex: Active Comparator	Drug: Condroflex (Zodiac)
Glucosamine/chondroitin sulphate: Experimental Glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal	Drug: Glucosamine sulphate and chondroitin sulphate association glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal

Detailed Description:

To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Condroflex® (Zodiac) in same presentation and pharmaceutical form.

Some eligibility criteria:

Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) > 40 mm; Clinical diagnosis of pain and functional limitation

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study.
Male or female Subjects, aged upper to 40 years.
Osteoarthritis of the knee confirmed by radiological examination.
Visual analogue scale (VAS) > 40 mm.
Kellgren and Lawrence grade 1 to 3.
Clinical diagnosis of pain and functional limitation.

Exclusion Criteria:

History of significant trauma or surgery in the affected joint.
Pregnant women, lactating or not using appropriate contraceptive method.
History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis.
Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation <40mm/h and rheumatoid factor <1:40).
Body mass index > 30.
Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria).
Systemic administration and/or intra-articular corticosteroids in the last 3 months.
Have made use of glucosamine and/or chondroitin.
Lequesne index of > 12.
Arthroplasty in the affected joint.
Use of narcotic analgesics.
Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955552

Contacts

Contact: Carine M. Sanches, Coordinator

+55 11 5090 8727

carine.martins@eurofarma.com.br

Locations

Brazil
Irmandade da Santa Casa de Misericordia de Sao Paulo
Sao Paulo, Brazil, 01221-010
Instituto de Medicina Avancada
Sao Paulo, Brazil, 05437-000
Centro Paulista de Investigacoes Clinicas Ltda
Sao Paulo, Brazil, 04266-010
Brazil, Sao Paulo
Instituto de Pesquisa Clínica e Assistencia Medica de Campinas
Campinas, Sao Paulo, Brazil, 13073-350

Sponsors and Collaborators

Eurofarma Laboratorios Ltda

Investigators

Principal Investigator:	Branca B. Souza, Phd/MD	Irmandade da Santa Casa de Misericordia de Sao Paulo
Principal Investigator:	Marise L. Castro, Phd/MD	Instituto de Medicina Avancada
Principal Investigator:	Cristiano F. Zerbini, Phd/MD	Centro Paulista de Investigacoes Clínicas Ltda.
Principal Investigator:	Jose A. Mendonça, Phd/MD	Instituo de Pesquisa Clínica e Assistencia Medica de Campinas

More Information

No publications provided

Responsible Party:	Eurofarma Laboratorios Ltda ( Carine Martins Sanches )
Study ID Numbers:	EF-093-00
Study First Received:	August 5, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955552 History of Changes
Health Authority:	Brazil: Ethics Committee; Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios Ltda:

osteoarthritis (OA)
knee

Study placed in the following topic categories:

Osteoarthritis, Knee
Chondroitin
Musculoskeletal Diseases
Osteoarthritis

Glucosamine
Arthritis
Joint Diseases
Rheumatic Diseases

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009