Knee OsteoarthritisVESTANCT01469507
Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis
A study testing Chondroitin sulfate and sodium hyaluronate and Hyaluronan in people with Knee Osteoarthritis, run by Pierre Fabre Medicament.
Trial summary
The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections. Chondroitin sulfate is one of the components of cartilage. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Chondroitin sulfate and sodium hyaluronate and Hyaluronan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months
- patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy
Who cannot join
- isolated symptomatic femoropatellar osteoarthritis
- target knee prothesis
- having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation,
- target knee osteoarthritis with clinical joint effusion at selection and at randomization
- body mass index (BMI) greater than or equal to 30,
- patient having received any corticosteroid treatment by any administration route (other than inhalers, ocular, auricular route) in the month preceding randomisation,
- patient having received intra-articular steroid injection in the target knee within the month preceding randomisation or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding randomisation
About this study
Official title: Comparative Study of Efficacy and Safety of Three Intra Articular Injections of V0220 Versus Hyalgan® in Patients Suffering From Symptomatic Knee Osteoarthritis. A Multinational Multicentric, Randomised, Double-blind, Parallel-group Study
The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections.
Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow ("outflow buffering").
- Conditions
- Knee Osteoarthritis
- Being tested
- Chondroitin sulfate and sodium hyaluronate, Hyaluronan
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulfate and sodium hyaluronateDevice
3 weekly injections
HyaluronanDrug
Also called Hyalgan®
3 weekly injections
| Study group | Role | What they receive |
|---|---|---|
| V0220 | Experimental | Not described Receives: Device: Chondroitin sulfate and sodium hyaluronate |
| Hyaluronan | Active comparator | Not described Receives: Drug: Hyaluronan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief assessed on a global pain Visual Analogic Scale
Measured: change from baseline over 24 weeks
Secondary outcomes (6)
Functional improvement (questionnaire)
Measured: change from baseline over 24 weeks
Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
Measured: change from baseline over 24 weeks
Patient's health related quality of life (questionnaire)
Measured: over 24 weeks
Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
Measured: over 24 weeks
Medico-economic questionnaire
Measured: over 24 weeks
Occurrence of adverse events
Measured: over 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel MAHEU, Dr, Principal investigator, private practice / unaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469507
- Sponsor's protocol ID
- V00220 IA 0 01
- Other IDs
- 2011-002295-17
- Acronym
- VESTA
- Status last verified
- Feb 2013
- First submitted
- 7 Nov 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Efficacy and Safety of Three Intra Articular Injections of V0220 Versus Hyalgan® in Patients Suffering From Symptomatic Knee Osteoarthritis. A Multinational Multicentric, Randomised, Double-blind, Parallel-group Study
- ClinicalTrials.gov ID
- NCT01469507
- Acronym / sponsor ID
- VESTA / V00220 IA 0 01
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- First posted
- 10 Nov 2011 (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.
The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections.
Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow ("outflow buffering").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V0220 | Experimental | Device: Chondroitin sulfate and sodium hyaluronate |
| Hyaluronan | Active comparator | Drug: Hyaluronan |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months
- patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy
Key exclusion criteria (7 listed)
- isolated symptomatic femoropatellar osteoarthritis
- target knee prothesis
- having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation,
- target knee osteoarthritis with clinical joint effusion at selection and at randomization
- body mass index (BMI) greater than or equal to 30,
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 |
|---|---|---|
| Chondroitin sulfate and sodium hyaluronate3 weekly injections | Device | V0220 |
| HyaluronanAlso: Hyalgan®3 weekly injections | Drug | Hyaluronan |
Primary outcome
Pain relief assessed on a global pain Visual Analogic Scale
Time frame: change from baseline over 24 weeks
6 secondary outcomes
Functional improvement (questionnaire)
Time frame: change from baseline over 24 weeks
Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
Time frame: change from baseline over 24 weeks
Patient's health related quality of life (questionnaire)
Time frame: over 24 weeks
Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
Time frame: over 24 weeks
Medico-economic questionnaire
Time frame: over 24 weeks
Occurrence of adverse events
Time frame: over 24 weeks
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 21 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.
Emmanuel MAHEU, Dr principal investigator
private practice / unaffiliated
Questions about this trial
What is this clinical trial studying?
A study testing Chondroitin sulfate and sodium hyaluronate and Hyaluronan in people with Knee Osteoarthritis, run by Pierre Fabre Medicament.
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 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 21 Feb 2013. 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.
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?
Pain relief assessed on a global pain Visual Analogic Scale (time frame: change from baseline over 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 21 Feb 2013.