Osteoarthritis, HipNCT01618708

A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

A study testing Synvisc-One (hylan G-F 20) in people with Osteoarthritis, Hip, run by Genzyme, a Sanofi Company at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Osteoarthritis, Hip
What is being tested?: Synvisc-One (hylan G-F 20)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 357 participants
Where: 48 sitesin 2 countries
Study dates: Sep 2012to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The participant had symptomatic osteoarthritis (OA) in the target joint
The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year

Who cannot join

The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed)
The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception
The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen
The participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography [CT] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure

Show all 10Show fewer

The participant had active infection in the area of the injection site
The participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of Screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications
The participant used an investigational drug, device or biologic within 12 weeks of Screening
The participant had any significant medical condition that the Investigator feels would interfere with study evaluations and study participation

Trial locations and contacts

48 sites in 2 countries.

Country

City, postcode or hospital

48 sites in 2 countries

United States45 sites

Investigational Site Number 840013
Altoona, Pennsylvania, 16635
Investigational Site Number 840024
Amherst, New York, 14226
Investigational Site Number 840044
Asheville, North Carolina, 28801
Investigational Site Number 840054
Austin, Texas, 78751
Investigational Site Number 840040
Bedford, Texas, 76021
Investigational Site Number 840011
Bradenton, Florida, 84020
Investigational Site Number 840025
Burmingham, Alabama, 35216
Investigational Site Number 840016
Charlottesville, Virginia, 22901
Investigational Site Number 840002
Chicago, Illinois, 60611
Investigational Site Number 840046
Columbus, Ohio, 43213
Investigational Site Number 840023
Covina, California, 91723
Investigational Site Number 840010
Dallas, Texas, 75235
Investigational Site Number 840009
Draper, Utah, 84020
Investigational Site Number 840048
Egg Harbor, New Jersey, 08234
Investigational Site Number 840050
Farmington, Connecticut, 06033
Investigational Site Number 840036
Fort Lauderdale, Florida, 33316
Investigational Site Number 840029
Hartsdale, New York, 10530
Investigational Site Number 840017
Jupiter, Florida, 33458
Investigational Site Number 840058
La Mesa, California, 91942
Investigational Site Number 840012
Lexington, Kentucky, 40509
Investigational Site Number 840039
Marietta, Georgia, 30060
Investigational Site Number 840052
Memphis, Tennessee, 38163
Investigational Site Number 840005
Meridian, Idaho, 83642
Investigational Site Number 840026
Mt. Pleasant, South Carolina, 29464
Investigational Site Number 840038
New Port Richey, Florida, 34652
Investigational Site Number 840041
Pensacola, Florida, 32504
Investigational Site Number 840055
Philadelphia, Pennsylvania, 19107
Investigational Site Number 840042
Phoenix, Arizona, 85016
Investigational Site Number 840056
Phoenix, Arizona, 85027
Investigational Site Number 840028
Raleigh, North Carolina, 27612
Investigational Site Number 840018
Reading, Pennsylvania, 19611
Investigational Site Number 840007
Reno, Nevada, 89502
Investigational Site Number 840014
Rochester, New York, 14609
Investigational Site Number 840032
Salt Lake City, Utah, 84107
Investigational Site Number 840022
Santa Monica, California, 90904
Investigational Site Number 840047
Sarasota, Florida, 34232
Investigational Site Number 840003
Seattle, Washington, 98166
Investigational Site Number 840049
South Miami, Florida, 33134
Investigational Site Number 840037
St Louis, Missouri, 63128
Investigational Site Number 840027
Stamford, Connecticut, 06905
Investigational Site Number 840033
Traverse City, Michigan, 49648
Investigational Site Number 840004
Tucson, Arizona, 85712
Investigational Site Number 840051
Waterbury, Connecticut, 06708
Investigational Site Number 840043
Wichita, Kansas, 67203
Investigational Site Number 840045
Wilmington, North Carolina, 28401

Other trials in United States

Canada3 sites

Investigational Site Number 124091
London, N6C 4R3
Investigational Site Number 124093
Montreal, H4N 3C5
Investigational Site Number 124092
Sherbrooke, J1H 1Z1

Other trials in Canada

About this study

Official title: A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Conditions: Osteoarthritis, Hip
Being tested: Synvisc-One (hylan G-F 20), Placebo
Medical subject headings: Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Synvisc-One (hylan G-F 20)Device
6-mL IA injection
PlaceboDevice
6 mL injection of phosphate buffered saline

Study groups in NCT01618708
Study group	Role	What they receive
Synvisc-One	Experimental	Single intraarticular (IA) injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period. Receives: Device: Synvisc-One (hylan G-F 20)
Placebo	Placebo comparator	Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period. Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Measured: From baseline to Week 26

Secondary outcomes (3)

Change From Baseline in WOMAC A Score Over 26 Weeks
WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Measured: From Baseline to Week 26
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.
Measured: From baseline to Week 26
Percentage of WOMAC A1 Responder Over 26 Weeks
WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.
Measured: From Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jun 2015

First posted13 Jun 2012 (estimated)
Study startSep 2012
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, HipStudies 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: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01618708
Sponsor's protocol ID: SYNV04910
Other IDs: EFC12791
Status last verified: May 2016
First submitted: 11 Jun 2012
Last updated: 11 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip
ClinicalTrials.gov ID: NCT01618708
Acronym / sponsor ID: SYNV04910
Conditions: Osteoarthritis, Hip
Study type: Interventional
Recruitment status: Completed
Enrolment: 357 participants (actual)
Lead sponsor: Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Jun 2012 (estimated)
Results: Posted 11 Jul 2016

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 was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Synvisc-One	Experimental	Device: Synvisc-One (hylan G-F 20)Single intraarticular (IA) injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Placebo	Placebo comparator	Device: PlaceboSingle IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The participant had symptomatic osteoarthritis (OA) in the target joint
The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year

Key exclusion criteria (10 listed)

The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed)
The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception
The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen

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
Synvisc-One (hylan G-F 20)6-mL IA injection	Device	Synvisc-One
Placebo6 mL injection of phosphate buffered saline	Device	Placebo

Primary outcome

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
Time frame: From baseline to Week 26
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.

3 secondary outcomes

Change From Baseline in WOMAC A Score Over 26 Weeks
Time frame: From Baseline to Week 26
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
Time frame: From baseline to Week 26
Percentage of WOMAC A1 Responder Over 26 Weeks
Time frame: From Baseline to Week 26

Results and safety

Results posted to the registry on 11 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	175	131
Synvisc-One	182	136

Primary outcome: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks

Time frame: From baseline to Week 26. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 175	Synvisc-One n = 182
Value	-2.26 (0.17)	-2.19 (0.16)

Placebo vs Synvisc-One: Least Squares (LS) Mean difference: 0.07 (95% CI -0.38 to 0.52), p = 0.7462, Mixed Models Analysis

Population analysed: ITT population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	15 of 172 (8.7%)	33 of 172 (19.2%)	Not reported
Synvisc-One	10 of 180 (5.6%)	43 of 180 (23.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis, Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.

Medical Monitor study director

Genzyme, a Sanofi Company

48 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Synvisc-One (hylan G-F 20) in people with Osteoarthritis, Hip, run by Genzyme, a Sanofi Company at 48 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 10 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks (time frame: From baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01618708.

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 11 Jul 2016.