Clinical trial NCT00955552: Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis (OA)
knee
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2009-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: approximately 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clínica e Assistencia Medica de Campinas
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Centro Paulista de Investigacoes Clinicas Ltda
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica Perdizes
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Avancada
Study officials:
affiliation: Centro de Pesquisa Clínica Perdizes
name: Gilberto Brandão, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Avancada
name: Marise L. Castro, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Paulista de Investigacoes Clínicas Ltda.
name: Cristiano F. Zerbini, Phd/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituo de Pesquisa Clínica e Assistencia Medica de Campinas
name: Jose A. Mendonça, Phd/MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lomonte ABV, Mendonca JA, de Castro Brandao G, Castro ML. Multicenter, randomized, double-blind clinical trial to evaluate efficacy and safety of combined glucosamine sulfate and chondroitin sulfate capsules for treating knee osteoarthritis. Adv Rheumatol. 2018 Dec 5;58(1):41. doi: 10.1186/s42358-018-0041-9.