OsteoarthrosisPhase 3NCT00860873
Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis
A Phase 3 study testing EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder), EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) and Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder) in people with Osteoarthrosis, run by Azidus Brasil at 1 site in Brazil.
Trial summary
This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder), EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) and Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Nov 2010
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who agree with all aspects of the study and sign the Informed Consent;
- Patients of both sexes;
- Age above 30 years;
- Clinical and radiological diagnosis of osteoarthritis;
- Osteoarthritis in grades 1-2;
- Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.
Who cannot join
- Patients with a history of trauma clinically significant;
- Patients who underwent surgery on joints affected;
- Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
- Pregnant patients and / or breastfeeding;
- Patients with phenylketonuria;
- Patients with clinical diagnosis of severe renal failure;
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- Patients with clinical diagnosis of severe liver disease;
- Patients with clinical diagnosis of clotting disorders;
- Patients who are being treated with anti-aggregating and / or anticoagulants;
- Patients with sensitive components of the formula;
- Patients with emotional disorders that interfere with the capture of data;
- Patients who do not agree with the purposes of the study and did not sign the Informed Consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
About this study
Official title: Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of "Chondroitin + Glucosamine Sulfate" Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.
This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.
- Conditions
- Osteoarthrosis
- Being tested
- EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder), EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules), Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder), Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)Dietary supplement
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)Dietary supplement
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)Dietary supplement
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)Dietary supplement
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | Oral Powder EMS Receives: Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder) |
| Test 2 | Experimental | Hard Capsules EMS Receives: Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) |
| Comparator 1 | Active comparator | Oral Powder Zodiac Receives: Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder) |
| Comparator 2 | Active comparator | Hard capsules - Zodiac Receives: Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in pain.
Measured: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860873
- Sponsor's protocol ID
- CGSEMS1108
- Status last verified
- Feb 2013
- First submitted
- 26 Nov 2008
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of "Chondroitin + Glucosamine Sulfate" Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.
- ClinicalTrials.gov ID
- NCT00860873
- Acronym / sponsor ID
- CGSEMS1108
- Conditions
- Osteoarthrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Mar 2009 (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.
This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)Oral Powder EMS |
| Test 2 | Experimental | Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)Hard Capsules EMS |
| Comparator 1 | Active comparator | Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)Oral Powder Zodiac |
| Comparator 2 | Active comparator | Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)Hard capsules - Zodiac |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who agree with all aspects of the study and sign the Informed Consent;
- Patients of both sexes;
- Age above 30 years;
- Clinical and radiological diagnosis of osteoarthritis;
- Osteoarthritis in grades 1-2;
Key exclusion criteria (12 listed)
- Patients with a history of trauma clinically significant;
- Patients who underwent surgery on joints affected;
- Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
- Pregnant patients and / or breastfeeding;
- Patients with phenylketonuria;
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 |
|---|---|---|
| EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg | Dietary supplement | Test 1 |
| EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg | Dietary supplement | Test 2 |
| Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg | Dietary supplement | Comparator 1 |
| Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg | Dietary supplement | Comparator 2 |
Primary outcome
Decrease in pain.
Time frame: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (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 25 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder), EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) and Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder) in people with Osteoarthrosis, run by Azidus Brasil at 1 site in Brazil.
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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Decrease in pain. (time frame: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 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 25 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.