Knee OsteoarthritisPhase 3HymovisNCT01372475
Hymovis™ Versus Placebo in Knee Osteoarthritis
A Phase 3 study testing Hymovis Intra-articular Injection and Phosphate Buffered Saline Injection in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 33 sites in 2 countries.
Trial summary
Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic 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 Intra-articular Injection and Phosphate Buffered Saline Injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Mar 2011to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
- Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
- Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study
Who cannot join
- Clinically significant apparent large effusion of the target knee;
- Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
- Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
- Medical history of anaphylactic reactions
- History of septic arthritis in any joint
- Females who are pregnant or breast-feeding
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States32 sites
Blair Orthopedics Associates & Sports Medicine
Altoona, Pennsylvania
Radiant Research
Anderson, South Carolina
Tekton Research
Austin, Texas
Achieve Clinical Research, LLC
Birmingham, Alabama
Sonora Clinical Research
Boise, Idaho
Rush University
Chicago, Illinois
Tampa Bay Medical Research
Clearwater, Florida
Columbus Clinical Research
Columbus, Ohio
Radiant Research
Columbus, Ohio
Homestead Clinical Research
Cutler Bay, Florida
SJS Clinical Research
DeFuniak Springs, Florida
Avail Clinical Research
DeLand, Florida
Altoona Center for Clinical Research
Duncansville, Pennsylvania
Riverside Clinical Research
Edgewater, Florida
Core Orthopaedic
Encinitas, California
Radiant Research
Greer, South Carolina
The Andrews Institute
Gulf Breeze, Florida
Drug Studies America
Marietta, Georgia
Benchmark Research
Metairie, Louisiana
Sun Coast Clinical Research
New Port Richey, Florida
Better Health Clinical Research
Newnan, Georgia
Norwalk Medical Group
Norwalk, Connecticut
Pensacola Research Consultants
Pensacola, Florida
Shores Rheumatology
Saint Clair Shores, Michigan
San Diego Clinical Trials
San Diego, California
Orthopaedic Specialty Clinic
Spokane, Washington
Stamford Therapeutics Consortium
Stamford, Connecticut
University Orthopedic Center
State College, Pennsylvania
Lakeview Medical Research
Summerfield, Florida
Martin Diagnostic Center
Tomball, Texas
Tucson Orthopaedic Institute
Tucson, Arizona
UMass Memorial Medical Center
Worcester, Massachusetts
About this study
Official title: A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension
Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic osteoarthritis of the knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hymovis Intra-articular Injection, Phosphate Buffered Saline Injection
- Keywords
- Osteoarthritis, Knee, Hyaluronan, Hyaluronic Acid, 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.
Hymovis Intra-articular InjectionDevice
Also called HYADD4™, Hyaluronic Acid, HA, Hyaluronate
Hymovis Intra-articular injection
Phosphate Buffered Saline InjectionProcedure or surgery
Also called PBS, Saline
Placebo Intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Hymovis Viscoelastic Hydrogel | Active comparator | Intra-articular Injection Receives: Device: Hymovis Intra-articular Injection |
| Placebo | Placebo comparator | Phosphate Buffered Saline Intra-articular Injection Receives: Procedure: Phosphate Buffered Saline Injection |
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
WOMAC A Pain sub-score
Measured: 26 weeks
Secondary outcomes (9)
Responder Analysis
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
Measured: 26 weeks
WOMAC Function
WOMAC C Function sub-score
Measured: 26 Weeks
Visual Analog Scale (VAS) WOMAC Pain
Question A1 of WOMAC Pain sub-score
Measured: 26 Weeks
WOMAC Global Score
Measured: 26 Weeks
WOMAC Stiffness sub-score
WOMAC C stiffness sub-score
Measured: 26 Weeks
Rescue Medication Usage Pill Count, Failure Outcome
Measured: 26 Weeks
Patient Global Analysis
Measured: 26 Weeks
Clinician Responder Analysis
Measured: 26 Weeks
SF Health Outcome
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 posted14 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionFeb 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia Secchieri, PhD, Study director, Fidia Farmceutici S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372475
- Sponsor's protocol ID
- R29-09-02
- Acronym
- Hymovis
- Status last verified
- Mar 2014
- First submitted
- 10 Jun 2011
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension
- ClinicalTrials.gov ID
- NCT01372475
- Acronym / sponsor ID
- Hymovis / R29-09-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Hyaluronan, Hyaluronic Acid, Viscoelastic, Hydrogel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Jun 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.
Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hymovis Viscoelastic Hydrogel | Active comparator | Device: Hymovis Intra-articular InjectionIntra-articular Injection |
| Placebo | Placebo comparator | Procedure: Phosphate Buffered Saline InjectionPhosphate Buffered Saline 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 (3 listed)
- Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
- Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
- Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study
Key exclusion criteria (6 listed)
- Clinically significant apparent large effusion of the target knee;
- Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
- Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
- Medical history of anaphylactic reactions
- History of septic arthritis in any joint
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 |
|---|---|---|
| Hymovis Intra-articular InjectionAlso: HYADD4™, Hyaluronic Acid, HA, HyaluronateHymovis Intra-articular injection | Device | Hymovis Viscoelastic Hydrogel |
| Phosphate Buffered Saline InjectionAlso: PBS, SalinePlacebo Intra-articular injection | Procedure or surgery | Placebo |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
Time frame: 26 weeks
WOMAC A Pain sub-score
9 secondary outcomes
Responder Analysis
Time frame: 26 weeks
WOMAC Function
Time frame: 26 Weeks
Visual Analog Scale (VAS) WOMAC Pain
Time frame: 26 Weeks
WOMAC Global Score
Time frame: 26 Weeks
WOMAC Stiffness sub-score
Time frame: 26 Weeks
Rescue Medication Usage Pill Count, Failure Outcome
Time frame: 26 Weeks
Patient Global Analysis
Time frame: 26 Weeks
Clinician Responder Analysis
Time frame: 26 Weeks
SF Health Outcome
Time frame: 26 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 8 Apr 2014.
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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.
Cynthia Secchieri, PhD study director
Fidia Farmceutici S.p.A.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hymovis Intra-articular Injection and Phosphate Buffered Saline Injection in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 33 sites in 2 countries.
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 6 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Puerto Rico. 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?
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?
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 8 Apr 2014.