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

Osteoarthritis of the Knee Clinical Trial

— Artico  

Official title:

A Multi-center, Randomized, Double Blind, Comparative of Efficacy and Safety From Association of Capsules Glucosamine and Chondroitin Sulfate (Eurofarma) Versus Cosamin DS to Treatment With Osteoarthrosis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955552
• Other study ID #: EF-093
• Status: Completed
• Phase: Phase 3
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2022
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 Cosamin DS® (Nutramax) 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Glucosamine sulphate and chondroitin sulphate association
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
• Cosamin DS® (Nutramax)
oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clínica e Assistencia Medica de Campinas	Campinas	Sao Paulo
Brazil	Centro de Pesquisa Clínica Perdizes	Sao Paulo
Brazil	Centro Paulista de Investigacoes Clinicas Ltda	Sao Paulo
Brazil	Instituto de Medicina Avancada	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form	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 Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.	approximately 5 months