Osteoarthritis of the KneePhase 3ArticoNCT00955552

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

A Phase 3 study testing Glucosamine sulphate and chondroitin sulphate association and Cosamin DS® (Nutramax) in people with Osteoarthritis of the Knee, run by Eurofarma Laboratorios S.A. at 4 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: Glucosamine sulphate and chondroitin sulphate association and Cosamin DS® (Nutramax)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesBrazil
Study dates: Aug 2010to Jun 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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 locations and contacts

4 sites in 1 country.

Brazil4 sites

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

Other trials in Brazil

About this study

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

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.

Read the 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

Conditions: Osteoarthritis of the Knee
Being tested: Glucosamine sulphate and chondroitin sulphate association, Cosamin DS® (Nutramax)
Keywords: osteoarthritis (OA), knee
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glucosamine sulphate and chondroitin sulphate associationDrug
Also called Glucosamine sulphate and Chondroitin sulphate
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
Cosamin DS® (Nutramax)Drug
Also called Cosamin DS®, glucosamine hydrochloride and chondroitin sulphate
oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Study groups in NCT00955552
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Glucosamine sulphate and chondroitin sulphate association

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: approximately 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jun 2011

First posted10 Aug 2009 (estimated)
Study startAug 2010
Primary completionFeb 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00955552
Sponsor's protocol ID: EF-093
Acronym: Artico
Status last verified: May 2022
First submitted: 5 Aug 2009
Last updated: 8 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30657100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00955552
Acronym / sponsor ID: Artico / EF-093
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis (OA), knee
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Feb 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 10 Aug 2009 (estimated)
Results: Posted 8 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Cosamin DS®	Active comparator	Drug: Cosamin DS® (Nutramax)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/ chondroitin sulphate	Experimental	Drug: Glucosamine sulphate and chondroitin sulphate associationGlucosamine 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Glucosamine sulphate and chondroitin sulphate associationAlso: Glucosamine sulphate and Chondroitin sulphateglucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal	Drug	Glucosamine/ chondroitin sulphate
Cosamin DS® (Nutramax)Also: Cosamin DS®, glucosamine hydrochloride and chondroitin sulphateoral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days	Drug	Cosamin DS®

Primary outcome

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.

Results and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cosamin DS®	50	44
Glucosamine/Chondroitin Sulphate	50	45

Primary outcome: 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. Mean (95% Confidence Interval). Unit: percentage of participants

Measure	Cosamin DS® n = 41	Glucosamine/Chondroitin Sulphate n = 45
Value	85.4 (70.1 to 93.4)	88.9 (75.2 to 95.8)

Cosamin DS® vs Glucosamine/Chondroitin Sulphate: p <0.05, t-test, 1 sided

Population analysed: In this section the population analyzed was per protocol (PP).

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cosamin DS®	3 of 50 (6%)	5 of 50 (10%)	Not reported
Glucosamine/Chondroitin Sulphate	1 of 50 (2%)	8 of 50 (16%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30657100Lomonte 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.

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilberto Brandão, Phd/MD principal investigator

Centro de Pesquisa Clínica Perdizes

Marise L. Castro, Phd/MD principal investigator

Instituto de Medicina Avancada

Cristiano F. Zerbini, Phd/MD principal investigator

Centro Paulista de Investigacoes Clínicas Ltda.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00955552, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.