Knee OsteoarthritisNCT02187549
Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
A study testing HYMOVIS in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 21 sites in United States.
Trial summary
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee. 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?
- HYMOVIS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2014to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the knee.
Who cannot join
- No disorders which could interfere with study required assessments.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Blair Orphopedics
Altoona, Pennsylvania, 16602
Great Lakes Research Group
Bay City, Michigan, 48706
Achieve Clinical Research
Birmingham, Alabama, 35216
Tufts Medical Center
Boston, Massachusetts, 02111
Alabama Clinical Therapeutics
Brimingham, Alabama, 35235
Med Center
Carmichael, California, 95608
New Horizons
Cincinnati, Ohio, 45242
Columbus Clinical Research
Columbus, Ohio, 43213
Riverside Clinical Research
Edgewater, Florida, 32132
Fabio Orozco
Egg Harbor, New Jersey, 08234
Triwest Research Associates
El Cajon, California, 92020
Colorado Orthopedic Consultants
Englewood, Colorado, 80110
Healthcare Research Network
Hazelwood, Missouri, 63042
West Houston Clinical Research
Houston, Texas, 77055
Suncoast Clinical Research
New Port Richey, Florida, 34652
Ormond Medical Arts
Ormond Beach, Florida, 32174
Elite Clinical Studies
Phoenix, Arizona, 85018
Arizona Research Center
Phoenix, Arizona, 85023
PMG Research of Raleigh
Raleigh, North Carolina, 27609
Westlake Medical
Thousand Oaks, California, 91360
Chase Medical
Waterbury, Connecticut, 06708
About this study
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- HYMOVIS, Placebo
- Keywords
- Hyaluronic Acid, Osteoarthritis, Knee, Hyaluronan, Viscoelastic, Hydrogel
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYMOVISDevice
Also called HYADD(TM) 4 Hydrogel Intra-Articular Injection
Intra-articular injection
PlaceboDevice
Also called Placebo Intra-Articular Injection
Intra-Articular Injection
| Study group | Role | What they receive |
|---|---|---|
| HYMOVIS | Experimental | HYADD(TM) 4 Hydrogel Intra-Articular Injection Receives: Device: HYMOVIS |
| Placebo | Placebo comparator | Saline Intra-Articular Injection Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
Measured: 26 weeks
Secondary outcomes (1)
Patient Global Assessment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (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, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187549
- Sponsor's protocol ID
- EQE7-13-01
- Status last verified
- Oct 2015
- First submitted
- 29 Jun 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02187549
- Acronym / sponsor ID
- EQE7-13-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyaluronic Acid, Osteoarthritis, Knee, Hyaluronan, Viscoelastic, Hydrogel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Jul 2014 (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 purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYMOVIS | Experimental | Device: HYMOVISHYADD(TM) 4 Hydrogel Intra-Articular Injection |
| Placebo | Placebo comparator | Device: PlaceboSaline Intra-Articular Injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic osteoarthritis of the knee.
Key exclusion criteria (1 listed)
- No disorders which could interfere with study required assessments.
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 |
|---|---|---|
| HYMOVISAlso: HYADD(TM) 4 Hydrogel Intra-Articular InjectionIntra-articular injection | Device | HYMOVIS |
| PlaceboAlso: Placebo Intra-Articular InjectionIntra-Articular Injection | Device | Placebo |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
Time frame: 26 weeks
1 secondary outcome
Patient Global Assessment
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYMOVIS in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 21 sites in United States.
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 1 inclusion and 1 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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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.
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?
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?
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score (time frame: 26 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 5 Oct 2015.