Osteoarthritis of KneePhase 3GLACIALNCT02830919

Clinical Study of Non-inferiority With Participants Diagnosed With Primary Knee OA (GLACIAL)

A Phase 3 study testing Glucosamine and chondroitin sulfate combination (Eurofarma) and Glucosamine and chondroitin sulfate combination (Zodic) in people with Osteoarthritis of 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

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis of Knee
What is being tested?: Glucosamine and chondroitin sulfate combination (Eurofarma) and Glucosamine and chondroitin sulfate combination (Zodic)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 627 participants
Where: 4 sitesBrazil
Study dates: 5 Dec 2016to 10 May 2019
Phase: Phase 3
Are there results?: None posted in the registry

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

Male and female patients meeting all the following criteria will be enrolled in the study:
Aged ≥ 40 years.
Clinical and radiological diagnosis of primary (idiopathic) arthrosis of knee according to the criteria of the American College of Rheumatology (ACR).
Kellgren and Lawrence radiological classification of degree 2 or 3 in x-ray of knee-target obtained in 3 months prior to the screening visit of the study.
Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
Visual analogue scale for evaluation of the pain of osteoarthritis of knee by the research participant in the screening visit ≥ 40 mm

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Average score ≥ 40 mm in the subscale of "pain" (from 0 to 100 mm) in the target knee of the questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in the randomization visit.
Functional class ACR from I to III.
Signing the Informed Consent Form (ICF) before the performance of any study procedure.

Who cannot join

Patients meeting at least one of the following criteria will be excluded from the study:
Diagnosis of septic arthritis, inflammatory arthritis (as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital joint abnormalities.
Presence of inflammatory signals (edema, erythema or joint effusion) in the target knee, considered to be clinically significant by investigator.
Serious target knee joint misalignment, defined by investigator.
Predominantly patellofemoral Osteoarthritis in the target knee.
Historical of severe trauma or surgery (including arthroscopy) in the target knee in the 6 months before the screening visit.

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Planned Surgery to the target knee
Symptomatic Osteoarthritis of the ipsilateral hip.
Use of non-steroidal anti-inflammatory, dipyrone and opioid analgesics or narcotics from the screening visit, or a washout period for these medicines less than those defined by the Protocol, before the randomization visit .
Oral Glucocorticoids, intravenously or intramuscularly in the 30 days prior to the screening visit.
Intraarticular corticosteroid Injection and/or hyaluronic acid in the target knee in 6 months prior to the screening visit.
Use of the following drugs in the periods described below, before the screening visit:
Diacerein, chloroquine or soybean and avocado unsaponifiables extracts in the last 3 months.
Duloxetine hydrochloride in the last 30 days.
Glucosamine Sulphate and/or chondroitin sulfate in the last 6 months.
Strontium ranelate for the past 6 months.
Historical of allergy or intolerance to treatment of the study or to paracetamol.
Physiotherapy or irregular practice of physical activity beginning in the 3 months prior to the screening visit.
Diagnosis of fibromyalgia, collagenosis or significative vascular/neurologica diseases in lower limbs that may confuse the analysis of the study.
Body mass index ≥ 40 kg/m2.
Need to use cane, crutches or a walker.
Presence of infectious hepatitis active or history of hepatitis medicinal products.
Results of ALT, AST and total bilirubin and fractions above the upper limit of normal.
Serum creatinine level above the upper limit of normal.
Fasting blood glucose > 110 mg/dL or glycated hemoglobin > 6.5%.
Use of anticoagulants.
Consumption of alcohol more than one dose a day (women) or two doses a day (men).
Presence of serious diseases or not controlled.
Planned surgery to occur during the period of participation in the study.
Presence of pregnancy or breastfeeding.
Women of childbearing potential must agree to use highly effective contraception.
Participation in a clinical trial protocol within the previous 12 months unless, at the investigator's discretion, his or her participation may imply a direct benefit for the participant.
Presence of any condition which, at the investigator's discretion, may consider the participation of the patient inadequate for the study.

Trial locations and contacts

4 sites in 1 country.

Brazil4 sites

Study site
Curitiba, Paraná
Study site
Goiânia, Goiás
Study site
Maringá, Paraná
Study site
São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: Phase III Clinical Study, Multicenter, Randomized, Single-blind, Parallel Groups for Safety Evaluation and Non-inferiority of Efficacy of Glucosamine Sulfate Plus Chondroitin Sulfate From Bovine Origin (Eurofarma Laboratorios S.A.) Versus Condroflex ® in the Treatment of Symptomatic Knee Primary Osteoarthritis

This phase III clinical study will be conducted in Brazilian research sites. It will be included in the study 314 participants diagnosed with primary knee OA according to the classification criteria of the ACR. After a washout period, the participants will be randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate + chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment period of the study will be of 24 weeks. Each participant will perform seven visits to the research site. The main evaluations will be the improve of pain in the target knee by questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and quality of life by SF-12 questionnaire.

Conditions: Osteoarthritis of Knee
Being tested: Glucosamine and chondroitin sulfate combination (Eurofarma), Glucosamine and chondroitin sulfate combination (Zodic)
Keywords: Osteoarthritis of knee, Glucosamine sulfate, Chondroitin sulfate
Medical subject headings: Osteoarthritis, Knee

What participants receive

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

Glucosamine and chondroitin sulfate combination (Eurofarma)Drug
Glucosamine and chondroitin sulfate combination (Zodic)Drug

Study groups in NCT02830919
Study group	Role	What they receive
Glucosamine and chondroitin sulfate combination (Eurofarma)	Experimental	Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Eurofarma Laboratórios S.A., administered once a day for 24 weeks. Receives: Drug: Glucosamine and chondroitin sulfate combination (Eurofarma)
Glucosamine and chondroitin sulfate combination (Zodiac)	Active comparator	Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Zodiac Produtos Farmacêuticos S.A. (Condroflex®), administered once a day for 24 weeks. Receives: Drug: Glucosamine and chondroitin sulfate combination (Zodic)

What is being measured

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

Absolute change of pain WOMAC subscale score 24 weeks after initiation of treatment.
Measured: 24 weeks

Secondary outcomes (4)

Absolute change the overall assessment of the disease by the investigator along treatment as measured by Visual Analog Scale from 0 to 100mm.
Measured: 24 weeks
Absolute change score of physical and mental components of the questionnaire SF-12 24 weeks after initiation of treatment compared to baseline.
Measured: 24 weeks
Incidence and profile of adverse events coded as MedDRA by treatment group.
Measured: 24 weeks
Frequency of treatment discontinuation for adverse events and laboratory abnormalities.
Measured: 24 weeks

Timeline

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

5 Dec 201610 May 2019

First posted13 Jul 2016 (estimated)
Study start5 Dec 2016
Primary completion10 May 2019
Study completion10 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis of 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: Single blind
Who is masked: Investigator
Enrolment: 627 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02830919
Sponsor's protocol ID: EF140
Acronym: GLACIAL
Status last verified: Oct 2019
First submitted: 7 Jul 2016
Last updated: 9 Oct 2019
Results posted: No
Data monitoring committee: No

Publications

Lomonte ABV, Gimenez E, da Silva AC, Radominski SC, Scheinberg MA, Ximenes AC, de Freitas Zerbini CA. Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial. Adv Rheumatol. 2021 Jan 19;61(1):7. doi: 10.1186/s42358-021-00165-9.
PubMed 33468249

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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All Osteoarthritis of Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Clinical Study, Multicenter, Randomized, Single-blind, Parallel Groups for Safety Evaluation and Non-inferiority of Efficacy of Glucosamine Sulfate Plus Chondroitin Sulfate From Bovine Origin (Eurofarma Laboratorios S.A.) Versus Condroflex ® in the Treatment of Symptomatic Knee Primary Osteoarthritis
ClinicalTrials.gov ID: NCT02830919
Acronym / sponsor ID: GLACIAL / EF140
Conditions: Osteoarthritis of Knee
Keywords: Osteoarthritis of knee, Glucosamine sulfate, Chondroitin sulfate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 627 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: 5 Dec 2016 (actual)
Primary completion: 10 May 2019 (actual)
Study completion: 10 May 2019 (actual)
First posted: 13 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Glucosamine and chondroitin sulfate combination (Eurofarma)	Experimental	Drug: Glucosamine and chondroitin sulfate combination (Eurofarma)Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Eurofarma Laboratórios S.A., administered once a day for 24 weeks.
Glucosamine and chondroitin sulfate combination (Zodiac)	Active comparator	Drug: Glucosamine and chondroitin sulfate combination (Zodic)Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Zodiac Produtos Farmacêuticos S.A. (Condroflex®), administered once a day for 24 weeks.

Who may qualify

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

Key inclusion criteria (9 listed)

Male and female patients meeting all the following criteria will be enrolled in the study:
Aged ≥ 40 years.
Clinical and radiological diagnosis of primary (idiopathic) arthrosis of knee according to the criteria of the American College of Rheumatology (ACR).
Kellgren and Lawrence radiological classification of degree 2 or 3 in x-ray of knee-target obtained in 3 months prior to the screening visit of the study.
Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.

Key exclusion criteria (33 listed)

Diagnosis of septic arthritis, inflammatory arthritis (as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital joint abnormalities.
Presence of inflammatory signals (edema, erythema or joint effusion) in the target knee, considered to be clinically significant by investigator.
Serious target knee joint misalignment, defined by investigator.
Predominantly patellofemoral Osteoarthritis in the target knee.
Historical of severe trauma or surgery (including arthroscopy) in the target knee in the 6 months before the screening visit.

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 and chondroitin sulfate combination (Eurofarma)	Drug	Glucosamine and chondroitin sulfate combination (Eurofarma)
Glucosamine and chondroitin sulfate combination (Zodic)	Drug	Glucosamine and chondroitin sulfate combination (Zodiac)

Primary outcome

Absolute change of pain WOMAC subscale score 24 weeks after initiation of treatment.
Time frame: 24 weeks

4 secondary outcomes

Absolute change the overall assessment of the disease by the investigator along treatment as measured by Visual Analog Scale from 0 to 100mm.
Time frame: 24 weeks
Absolute change score of physical and mental components of the questionnaire SF-12 24 weeks after initiation of treatment compared to baseline.
Time frame: 24 weeks
Incidence and profile of adverse events coded as MedDRA by treatment group.
Time frame: 24 weeks
Frequency of treatment discontinuation for adverse events and laboratory abnormalities.
Time frame: 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
Derived from this study: PubMed 33468249Lomonte ABV, Gimenez E, da Silva AC, Radominski SC, Scheinberg MA, Ximenes AC, de Freitas Zerbini CA. Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial. Adv Rheumatol. 2021 Jan 19;61(1):7. doi: 10.1186/s42358-021-00165-9.

Related trials for Osteoarthritis of 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
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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.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 9 inclusion and 33 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 9 Oct 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Absolute change of pain WOMAC subscale score 24 weeks after initiation of treatment. (time frame: 24 weeks). 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 NCT02830919, 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 9 Oct 2019.