OsteoarthritisPhase 3ZDPC00213NCT02448199
Study of Association of Anti-inflammatory and Anti-rheumatic
A Phase 3 study testing Meloxicam and Glucosamine, Meloxicam and Glucosamine in people with Osteoarthritis, run by Zodiac Produtos Farmaceuticos S.A..
Trial summary
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Meloxicam and Glucosamine, Meloxicam and Glucosamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs the Informed Consent Form
- Age between 40 and 85 years
- osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology
Who cannot join
- Cardiovascular disease
- Serious chronic comorbidity
- Hypersensitivity to any component of the study drugs
- body mass index> 30 kg / m²
Trial locations and contacts
No sites are listed yet.
Valery F Carvalho, Biologist contact
About this study
Official title: Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
Read the detailed description
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.
- Conditions
- Osteoarthritis
- Being tested
- Meloxicam and Glucosamine, Meloxicam, Glucosamine
- Keywords
- pain, Knee
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam and GlucosamineDrug
Also called Association Anti-inflamatory/Anti-rheumatic
Experimental
MeloxicamDrug
Also called Anti-inflamatory/Placebo
Active Comparator
GlucosamineDrug
Also called Anti-rheumatic/Placebo
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Kit 1 ( ML + CG ) + P | Experimental | One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet Receives: Drug: Meloxicam and Glucosamine |
| Kit 2 ( ML + P) | Active comparator | One tablet of meloxicam and one sachet of placebo once per day for 12 weeks Receives: Drug: Meloxicam |
| Kit 3 ( P+ GC) | Active comparator | One sachet of glucosamine and one tablet placebo once a day for 12 weeks Receives: Drug: Glucosamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment
Measured: 12 weeks
Secondary outcomes (1)
Safety measured by frequency of adverse event
Safety as measured by total frequency of adverse event during the 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda
- Responsible party
- Sponsor
- Investigators
- Edio Costa, Doctor, Study chair, CRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448199
- Sponsor's protocol ID
- Zodiac Produtos Farmacêuticos
- Acronym
- ZDPC00213
- Status last verified
- May 2015
- First submitted
- 11 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic
- ClinicalTrials.gov ID
- NCT02448199
- Acronym / sponsor ID
- ZDPC00213 / Zodiac Produtos Farmacêuticos
- Conditions
- Osteoarthritis
- Keywords
- pain, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Collaborators
- Eurotrials Brasil Consultores Cientificos Ltda
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 19 May 2015 (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.
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
Detailed description
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kit 1 ( ML + CG ) + P | Experimental | Drug: Meloxicam and GlucosamineOne sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet |
| Kit 2 ( ML + P) | Active comparator | Drug: MeloxicamOne tablet of meloxicam and one sachet of placebo once per day for 12 weeks |
| Kit 3 ( P+ GC) | Active comparator | Drug: GlucosamineOne sachet of glucosamine and one tablet placebo once a day for 12 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signs the Informed Consent Form
- Age between 40 and 85 years
- osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology
Key exclusion criteria (4 listed)
- Cardiovascular disease
- Serious chronic comorbidity
- Hypersensitivity to any component of the study drugs
- body mass index> 30 kg / m²
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 |
|---|---|---|
| Meloxicam and GlucosamineAlso: Association Anti-inflamatory/Anti-rheumaticExperimental | Drug | Kit 1 ( ML + CG ) + P |
| MeloxicamAlso: Anti-inflamatory/PlaceboActive Comparator | Drug | Kit 2 ( ML + P) |
| GlucosamineAlso: Anti-rheumatic/PlaceboActive Comparator | Drug | Kit 3 ( P+ GC) |
Primary outcome
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
Time frame: 12 weeks
Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment
1 secondary outcome
Safety measured by frequency of adverse event
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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.
Valery F Carvalho, Biologist contact
Edio Costa, Doctor study chair
CRM
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meloxicam and Glucosamine, Meloxicam and Glucosamine in people with Osteoarthritis, run by Zodiac Produtos Farmaceuticos 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 May 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carine F Sanches, Pharmacist (55 11 55015332, carine.sanches@zodiac.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment (time frame: 12 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 19 May 2015.