search
Back to results

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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Glucosamine sulphate and chondroitin sulphate association
Cosamin DS® (Nutramax)
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis (OA), knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto de Pesquisa Clínica e Assistencia Medica de Campinas
  • Centro Paulista de Investigacoes Clinicas Ltda
  • Centro de Pesquisa Clínica Perdizes
  • Instituto de Medicina Avancada

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cosamin DS®

Glucosamine/ chondroitin sulphate

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2009
Last Updated
May 12, 2022
Sponsor
Eurofarma Laboratorios S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT00955552
Brief Title
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis (OA), knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cosamin DS®
Arm Type
Active Comparator
Arm 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.
Arm Title
Glucosamine/ chondroitin sulphate
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Glucosamine sulphate and chondroitin sulphate association
Other Intervention Name(s)
Glucosamine sulphate and Chondroitin sulphate
Intervention Description
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
Intervention Type
Drug
Intervention Name(s)
Cosamin DS® (Nutramax)
Other Intervention Name(s)
Cosamin DS®, glucosamine hydrochloride and chondroitin sulphate
Intervention Description
oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
Primary Outcome Measure Information:
Title
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
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.
Time Frame
approximately 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilberto Brandão, Phd/MD
Organizational Affiliation
Centro de Pesquisa Clínica Perdizes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marise L. Castro, Phd/MD
Organizational Affiliation
Instituto de Medicina Avancada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristiano F. Zerbini, Phd/MD
Organizational Affiliation
Centro Paulista de Investigacoes Clínicas Ltda.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose A. Mendonça, Phd/MD
Organizational Affiliation
Instituo de Pesquisa Clínica e Assistencia Medica de Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Pesquisa Clínica e Assistencia Medica de Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13073-350
Country
Brazil
Facility Name
Centro Paulista de Investigacoes Clinicas Ltda
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Centro de Pesquisa Clínica Perdizes
City
Sao Paulo
ZIP/Postal Code
05005-001
Country
Brazil
Facility Name
Instituto de Medicina Avancada
City
Sao Paulo
ZIP/Postal Code
05437-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30657100
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs