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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Cosamin DS® (Nutramax); Drug: Glucosamine sulphate and chondroitin sulphate association

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955552

EF-093

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

Cosamin DS®

Active Comparator group

Description:

glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg (Cosamin DS®, Nutramax Laboratories). The medication was supplied as capsules, with the daily dose of 3 capsules.

Treatment:

Drug: Cosamin DS® (Nutramax)

Glucosamine/ chondroitin sulphate

Experimental group

Description:

Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal The medication was supplied as capsules, with the daily dose of 3 capsules.

Treatment:

Drug: Glucosamine sulphate and chondroitin sulphate association