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

NCT00955552 | Completed Phase 3 Results

• 1 other identifier: EF-093
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis (OA); knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cosamin DS®

ACTIVE COMPARATOR

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.

Drug: Cosamin DS® (Nutramax)

Glucosamine/ chondroitin sulphate

EXPERIMENTAL

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.

Drug: Glucosamine sulphate and chondroitin sulphate association

Interventions

Glucosamine sulphate and chondroitin sulphate association DRUG

glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal

Also known as: Glucosamine sulphate and Chondroitin sulphate

Glucosamine/ chondroitin sulphate

Cosamin DS® (Nutramax) DRUG

oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Also known as: Cosamin DS®, glucosamine hydrochloride and chondroitin sulphate

Cosamin DS®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (4)

Instituto de Pesquisa Clínica e Assistencia Medica de Campinas

Campinas, São Paulo, 13073-350, Brazil

Location

Centro Paulista de Investigacoes Clinicas Ltda

São Paulo, 04266-010, Brazil

Location

Centro de Pesquisa Clínica Perdizes

São Paulo, 05005-001, Brazil

Location

Instituto de Medicina Avancada

São Paulo, 05437-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30657100 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Glucosamine; Chondroitin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Glycosaminoglycans; Polysaccharides

Results Point of Contact

• Title: Eurofarma Laboratórios
• Organization: Eurofarma Laboratórios

08007043876

Study Officials

• Gilberto Brandão, Phd/MD

  Centro de Pesquisa Clínica Perdizes

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 10, 2009
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2022-05

Locations

BR (4)