TreatmentPhase 3ZD20108NCT00838487
Evaluate Safety & Efficacy of Condroflex in Subjects With OA
A Phase 3 study testing condroflex and exercise and sugar pill and exercise in people with Treatment and Osteoarthritis, run by Zodiac Produtos Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine +… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Treatment, Osteoarthritis, Elderly
- What is being tested?
- condroflex and exercise and sugar pill and exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Mar 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to have knee osteoarthritis degree 2 or 3
- to be capable to consent
Who cannot join
- previous drug treatment
- concomitant diseases
- concomitant drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
CRDB
São Paulo
Suely Roizenblatt, Dra., 55 11 5908-7081, suelyroi@gmail.com
Magda Bgnotto, Dra., 55 11 5908-7081, magda@afip.com.br
About this study
Official title: Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA
Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.
Read the detailed description
To have osteoarthritis degree 2 or 3 / To be capable to consent
- Conditions
- Treatment, Osteoarthritis, Elderly
- Being tested
- condroflex and exercise, sugar pill and exercise
- Keywords
- chondroitin, glucosamine, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
condroflex and exerciseOther
Also called glucosamine sulph + chondroitin sulph and therapeutic exerc.
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
sugar pill and exerciseOther
Also called Placebo Comparator and therapeutic exerc.
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| condroflex and exercise | Active comparator | assent arm Receives: Other: condroflex and exercise |
| sugar pill and exercise | Placebo comparator | sugar pill arm Receives: Other: sugar pill and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of pain
Measured: 12 week
Secondary outcomes (1)
rigidity restriction
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Suely Roizenblatt, Principal investigator, CRM Regional Council of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838487
- Sponsor's protocol ID
- ZODIAC
- Acronym
- ZD20108
- Status last verified
- Oct 2009
- First submitted
- 4 Feb 2009
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA
- ClinicalTrials.gov ID
- NCT00838487
- Acronym / sponsor ID
- ZD20108 / ZODIAC
- Conditions
- Treatment, Osteoarthritis, Elderly
- Keywords
- chondroitin, glucosamine, osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 6 Feb 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.
Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.
Detailed description
To have osteoarthritis degree 2 or 3 / To be capable to consent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| condroflex and exercise | Active comparator | Other: condroflex and exerciseassent arm |
| sugar pill and exercise | Placebo comparator | Other: sugar pill and exercisesugar pill arm |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to have knee osteoarthritis degree 2 or 3
- to be capable to consent
Key exclusion criteria (3 listed)
- previous drug treatment
- concomitant diseases
- concomitant drugs
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 |
|---|---|---|
| condroflex and exerciseAlso: glucosamine sulph + chondroitin sulph and therapeutic exerc.1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week | Other | condroflex and exercise |
| sugar pill and exerciseAlso: Placebo Comparator and therapeutic exerc.1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week | Other | sugar pill and exercise |
Primary outcome
improvement of pain
Time frame: 12 week
1 secondary outcome
rigidity restriction
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
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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.
Suely Roizenblatt principal investigator
CRM Regional Council of Medicine
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 condroflex and exercise and sugar pill and exercise in people with Treatment and Osteoarthritis, run by Zodiac Produtos Farmaceuticos S.A. 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 2 inclusion and 3 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 12 Oct 2009. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suely Roizenblatt (55 11 5908-7081, suelyroi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of pain (time frame: 12 week). 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 12 Oct 2009.