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

May 12, 2022 updated by: Eurofarma Laboratorios S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04266-010
        • Centro Paulista de Investigacoes Clinicas Ltda
      • Sao Paulo, Brazil, 05437-000
        • Instituto de Medicina Avancada
      • Sao Paulo, Brazil, 05005-001
        • Centro de Pesquisa Clínica Perdizes
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13073-350
        • Instituto de Pesquisa Clínica e Assistencia Medica de Campinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cosamin DS®

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: approximately 5 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Investigators

  • Principal Investigator: Gilberto Brandão, Phd/MD, Centro de Pesquisa Clínica Perdizes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (ESTIMATE)

August 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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