- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00955552
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee (Artico)
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 Overview
Status
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Carine M. Sanches, Coordinator
- Phone Number: +55 11 5090 8727
- Email: carine.martins@eurofarma.com.br
Study Locations
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-
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Sao Paulo, Brazil, 04266-010
- Centro Paulista de Investigacoes Clinicas Ltda
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Contact:
- Cristiano F. Zerbini, Phd/MD
- Phone Number: +55 11 2915 8325
- Email: criszerb@uol.com.br
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Principal Investigator:
- Cristiano F. Zerbini, Phd/MD
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Sao Paulo, Brazil, 05437-000
- Instituto de Medicina Avancada
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Contact:
- Marise L. Castro, PHd/MD
- Phone Number: +55 11 3863 9156
- Email: marise.lazaretti@imabrasil.com.br
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Principal Investigator:
- Marise L. Castro, Phd/MD
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Sao Paulo, Brazil, 05005-001
- Centro de Pesquisa Clínica Perdizes
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Sao Paulo
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Campinas, Sao Paulo, Brazil, 13073-350
- Instituto de Pesquisa Clínica e Assistencia Medica de Campinas
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Contact:
- Jose A. Mendonca, Phd/MD
- Phone Number: +55 19 3242 4077
- Email: mendoncaja@ig.com.br
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Principal Investigator:
- Jose A. Mendonca, Phd/MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals.
Period: 127 days
Other Names:
|
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.
|
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Gilberto Brandão, Phd/MD, Centro de Pesquisa Clínica Perdizes
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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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