Knee OsteoarthritisPhase 3SAVENCT03936192
A Parallel-group Active Comparator, Double-blind, Multicenter, Randomized, Double-blind, Phase III Clinical Study
A Phase 3 study testing glucosamine sulphate 1500mg and meloxicam 15mg and Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg in people with Knee Osteoarthritis, run by Eurofarma Laboratorios S.A..
Trial summary
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week, multicenter clinical study. Participants will be randomized 2: 2: 1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- glucosamine sulphate 1500mg and meloxicam 15mg and Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Feb 2021
- 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
- Age of 40 to 75 years (both inclusive).
- Clinical and radiological diagnosis of primary (idiopathic) knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
- Radiological classification of Kellgren and Lawrence of grades 2 or 3 on X-ray of the target knee.
- Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
- Visual analogue scale for evaluation of knee osteoarthritis pain by the research participant ≥ 40 mm at the screening visit.
- Mean score ≥ 40mm on the "pain" subscale (0 to 100mm) on the target knee of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the randomization visit.
- ACR functional class from I to III.
- Signature of the Informed Consent Form before performing any study procedure.
Who cannot join
- Diagnosis of septic arthritis, inflammatory arthritis (such as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital articular anomalies.
- Severe joint misalignment in the target knee, defined by the researcher.
- History of severe trauma or surgery (including arthroscopy) in the target knee within 6 months prior to the study selection visit.
- Symptomatic osteoarthritis of the ipsilateral hip.
- Use of non-steroidal anti-inflammatory, dipyrone, opioid or narcotic analgesics, collagen and herbal remedies for osteoarthritis from the screening visit, or a washout period for such drugs less than those defined by the protocol, prior to the visit randomization. The use of antidepressants and pain modulating medicinal products should not be started from the screening visit, but they should be kept stable during the study if they are already being used prior to the screening visit.
- Oral, intravenous or intramuscular corticosteroid therapy within 30 days prior to study visit visit.
- Intra-articular injection of corticosteroids, hyaluronic acid and / or platelet-rich plasma at the target knee within 6 months prior to the study selection visit.
About this study
Official title: Parallel-group Active Comparator, Double-blind, Randomized, Phase III Study to Assess Safety, Efficacy of Glucosamine Sulfate Plus Meloxicam vs Glucosamine Sulfate Plus Chondroitin Sulfate Primary Symptomatic Knee Osteoarthritis Treatment
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week, multicenter clinical study. Participants will be randomized 2: 2: 1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
Read the detailed description
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week treatment period, phase 3 comparative clinical study. Participants will be randomized 2:2:1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
- Conditions
- Knee Osteoarthritis
- Being tested
- glucosamine sulphate 1500mg and meloxicam 15mg, Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, Placebos
- 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 sulphate 1500mg and meloxicam 15mgDrug
Also called glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma)
glucosamine sulphate 1500mg plus meloxicam 15mg, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.
Glucosamine sulfate 1500mg and chondroitin sulfate 1200mgDrug
Also called glucosamine sulfate 1500mg and chondroitin sulfate 1200mg (Eurofarma)
Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)
PlacebosDrug
Placebo administered once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma) | Experimental | glucosamine sulfate 1500mg plus meloxicam 15mg combination, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks. Receives: Drug: glucosamine sulphate 1500mg and meloxicam 15mg |
| Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg | Active comparator | Glucosamine sulfate 1500mg plus Chondroitin Sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®), given once daily for 12 weeks. Receives: Drug: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg |
| Placebo | Placebo comparator | Placebo administered once daily for 12 weeks Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether the efficacy of glucosamine + meloxicam sulfate treatment is superior to the efficacy of treatment with glucosamine sulfate + chondroitin sulfate in improving pain in subjects with symptomatic primary knee OA treated for 4 weeks.
Absolute variation of the "pain" subscale score of the WOMAC questionnaire (0 to 100mm) 4 weeks (V2) after starting treatment in relation to the basal score (VR);
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study startJan 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- glucosamine sulphate 1500mg + meloxicam 15mg, produced by Eurofarma Laboratories S.A., administered once a day for 12 weeks. Glucosamine sulfate 1500mg + Chondroitin sulfate 1200mg, produced by Zodiac Pharmaceutical Products S.A. (Condroflex®), given once daily for 12 weeks. Placebo administered once daily for 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936192
- Sponsor's protocol ID
- EF 156
- Acronym
- SAVE
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2019
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel-group Active Comparator, Double-blind, Randomized, Phase III Study to Assess Safety, Efficacy of Glucosamine Sulfate Plus Meloxicam vs Glucosamine Sulfate Plus Chondroitin Sulfate Primary Symptomatic Knee Osteoarthritis Treatment
- ClinicalTrials.gov ID
- NCT03936192
- Acronym / sponsor ID
- SAVE / EF 156
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 3 May 2019 (actual)
- 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.
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week, multicenter clinical study. Participants will be randomized 2: 2: 1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
Detailed description
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week treatment period, phase 3 comparative clinical study. Participants will be randomized 2:2:1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- glucosamine sulphate 1500mg + meloxicam 15mg, produced by Eurofarma Laboratories S.A., administered once a day for 12 weeks. Glucosamine sulfate 1500mg + Chondroitin sulfate 1200mg, produced by Zodiac Pharmaceutical Products S.A. (Condroflex®), given once daily for 12 weeks. Placebo administered once daily for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma) | Experimental | Drug: glucosamine sulphate 1500mg and meloxicam 15mgglucosamine sulfate 1500mg plus meloxicam 15mg combination, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks. |
| Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg | Active comparator | Drug: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mgGlucosamine sulfate 1500mg plus Chondroitin Sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®), given once daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo administered once daily for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age of 40 to 75 years (both inclusive).
- Clinical and radiological diagnosis of primary (idiopathic) knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
- Radiological classification of Kellgren and Lawrence of grades 2 or 3 on X-ray of the target knee.
- Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
- Visual analogue scale for evaluation of knee osteoarthritis pain by the research participant ≥ 40 mm at the screening visit.
Key exclusion criteria (7 listed)
- Diagnosis of septic arthritis, inflammatory arthritis (such as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital articular anomalies.
- Severe joint misalignment in the target knee, defined by the researcher.
- History of severe trauma or surgery (including arthroscopy) in the target knee within 6 months prior to the study selection visit.
- Symptomatic osteoarthritis of the ipsilateral hip.
- Use of non-steroidal anti-inflammatory, dipyrone, opioid or narcotic analgesics, collagen and herbal remedies for osteoarthritis from the screening visit, or a washout period for such drugs less than those defined by the protocol, prior to the visit randomization. The use of antidepressants and pain modulating medicinal products should not be started from the screening visit, but they should be kept stable during the study if they are already being used prior to 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 sulphate 1500mg and meloxicam 15mgAlso: glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma)glucosamine sulphate 1500mg plus meloxicam 15mg, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks. | Drug | glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma) |
| Glucosamine sulfate 1500mg and chondroitin sulfate 1200mgAlso: glucosamine sulfate 1500mg and chondroitin sulfate 1200mg (Eurofarma)Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®) | Drug | Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg |
| PlacebosPlacebo administered once daily for 12 weeks. | Drug | Placebo |
Primary outcome
To assess whether the efficacy of glucosamine + meloxicam sulfate treatment is superior to the efficacy of treatment with glucosamine sulfate + chondroitin sulfate in improving pain in subjects with symptomatic primary knee OA treated for 4 weeks.
Time frame: 4 weeks
Absolute variation of the "pain" subscale score of the WOMAC questionnaire (0 to 100mm) 4 weeks (V2) after starting treatment in relation to the basal score (VR);
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glucosamine sulphate 1500mg and meloxicam 15mg and Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg in people with Knee Osteoarthritis, run by Eurofarma Laboratorios S.A..
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 whether the efficacy of glucosamine + meloxicam sulfate treatment is superior to the efficacy of treatment with glucosamine sulfate + chondroitin sulfate in improving pain in subjects with symptomatic primary knee OA treated for 4 weeks. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2022.