Osteoarthritis of the KneePhase 3NCT00988091
Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee
A Phase 3 study testing 1.2% Sodium Hyaluronate and Buffered Saline in people with Osteoarthritis of the Knee, run by Ferring Pharmaceuticals at 34 sites in United States.
Trial summary
Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- 1.2% Sodium Hyaluronate and Buffered Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 34 sitesUnited States
- Study dates
- Sep 2009to Apr 2011
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic osteoarthritis (OA) of target knee confirmed by American College of Rheumatology (ACR) Criteria.
- Pain due to OA in target knee present for at least 6 months.
- During Screening and Baseline visits, subjects will require a visual analog scale (VAS) score (100 mm) of ≥ 41 mm and ≤ 90 mm, recorded immediately following a 50-foot walk, AND at Baseline, cannot have decreased >10mm (improvement) from Screening.
- A bilateral standing anteroposterior (AP) X-ray confirming OA of the target knee.
- Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
- Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs).
- Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions.
- Signed Subject Informed Consent Form
Who cannot join
- Any major injury (including sports injuries) to the target knee within the prior 12 months.
- Any surgery to the target knee, hip and contralateral hip within the prior 12 months.
- Major and minor articular procedures
- Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis.
- Gout or calcium pyrophosphate (pseudogout) diseases of the target knee that have flared within the previous 6 months.
- X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee.
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- Osteonecrosis of either knee.
- Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication.
- Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee.
- Significant target knee joint infection or skin disorder/infection within the previous 6 months prior to study enrollment.
- Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee.
- Known hypersensitivity to acetaminophen, sodium hyaluronate, or phosphate buffered saline solution.
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.
- Recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders.
- Vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation.
- Current treatment or treatment within the previous 2 years prior to Screening for any malignancy unless specific written permission is provided by the Sponsor (excluding basal cell or squamous cell carcinoma of the skin).
- Chronic liver disease and active liver disease based on liver profile of aspartate aminotransferase (AST), alanine transaminase (ALT), and conjugated bilirubin >2 times the upper limit of normal.
- Renal insufficiency based on serum creatinine >2.0 mg/dL.
- Any clinically significant laboratory value based on clinical history that the Investigator feels may affect the study evaluation.
- Any intercurrent chronic disease or condition that may interfere with the completion of the 6-month (or 12-month) follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition.
- Current alcoholism, and/or any known current addiction to pain medications.
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study.
- Any psychiatric illness that would prevent comprehension of the details and nature of the study.
- Participation in any experimental device study within 6 months prior to the Screening, or an experimental drug study within 1 month prior to the Screening
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
International Physicians Research
Aventura, Florida
Northwest Clinical Research Center
Bellevue, Washington
Southbay Pharma Research
Buena Park, California
Providence Clinical Research
Burbank, California
Colorado Arthritis Center, PC
Englewood, Colorado
Investigational Site
Fort Lauderdale, Florida
Texas Orthopedic Specialists, PA
Grapevine, Texas
Apex Clinical Trials, LLC
Homewood, Alabama
St. Joseph's Mercy Clinic
Hot Springs, Arkansas
Memorial Bone & Joint Research Foundation
Houston, Texas
Holston Medical Group
Kingsport, Tennessee
Triwest Research Associates
La Mesa, California
Sunrise Medical Research
Lauderdale Lakes, Florida
Tri-County Orthopaedic Center
Leesburg, Florida
Rx Medical Research of Arkansas, Inc
Little Rock, Arkansas
UCLA-Division of Rheumatology
Los Angeles, California
Georgia Institute for Clinical Research
Marietta, Georgia
Pinnacle Orthopaedics and Sports Medicine
Marietta, Georgia
McKenzie Medical Center
McKenzie, Tennessee
Palmetto Medical Research
Mt. Pleasant, South Carolina
Research Department, Bone & Joint Hospital at St. Anthony
Oklahoma City, Oklahoma
New Jersey Physicians, LLC
Passaic, New Jersey
Black Hills Orthopedic & Spine Center
Rapid City, South Dakota
Discovery Clinical Trials (DCT) - Stone Oak, LLC
San Antonio, Texas
Investigational Site
Santa Barbara, California
Lee Research Institute
Shawnee, Kansas
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina
New England Research Associates, LLC
Trumball, Connecticut
Tucson Orthopaedic Institute
Tucson, Arizona
Omega Medical Research
Warwick, Rhode Island
Clinical Research Center LLC
Wellington, Florida
Front Range Clinical Research
Wheat Ridge, Colorado
Professional Research Network of Kansas
Wichita, Kansas
National Pain Research Institute, LLC
Winter Park, Florida
About this study
Official title: A 26 Week, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Single Intra-Articular Injection 1.2% Sodium Hyaluronate for Treatment of Painful Osteoarthritis of the Knee, With Optional 26-Week Open-Label Safety Extension
Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- 1.2% Sodium Hyaluronate, Buffered Saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.2% Sodium HyaluronateDevice
Also called sodium hyaluronate
IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).
Buffered SalineDevice
Also called saline
IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.
| Study group | Role | What they receive |
|---|---|---|
| IA-SA | Placebo comparator | Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks. Receives: Device: Buffered Saline |
| IA-BioHA | Experimental | Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks. Receives: Device: 1.2% Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26
The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.
Measured: Day 0 (baseline) through Week 26
Secondary outcomes (6)
Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26
Adjusted mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm = no pain, stiffness and difficulty; 100 mm = extreme pain, stiffness and difficulty. Change from baseline calculated as: Week 26 minus baseline.
Measured: Day 0 (baseline), week 26
Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.
The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score. The percent of participants who showed a 20mm or greater improvement in the pain scores at week 26 compared to baseline are reported.
Measured: Day 0 (baseline), Week 26
Subjective Patient Assessment of Treatment at Week 26
At the end of the double-blind period (week 26), participants were asked: "Are you satisfied with the results of the injection?" Answers could be: 1=dissatisfied; 2=slightly satisfied; 3=satisfied; or 4=very satisfied.
Measured: Week 26
Number of Tablets of Rescue Medication Used Between Visits
Acetaminophen (500-mg tablets) was provided to study participants as a rescue medication in case they needed a pain medication during the study. The mean number of tablets of rescue medication should have been summarized, however the data was not captured in a reliable way and is therefore not reported.
Measured: Day 1 to week 26
Change From Baseline in Patient Global Assessment at Week 26
Participants were asked to mark along a 100mm visual analog scale (VAS) indicating the point best representing the severity of the knee pain that day. The left side of the VAS was 0=no pain and the right side was 100 = extreme pain. Change from baseline was calculated as Week 26 - Baseline.
Measured: Day 0 (baseline), Week 26
Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26
Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function (WOMAC Disability score) and global assessment (Patient Global Assessment Score) scales. Each of the individual scales was completed by the participant. A responder showed considerable improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. Response at Week 26 is compared to baseline.
Measured: Day 0 (baseline), week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionApr 2011
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 of the KneeStudies 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, Care provider, Investigator
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988091
- Sponsor's protocol ID
- 2009-03
- Status last verified
- Jun 2012
- First submitted
- 29 Sep 2009
- Last updated
- 15 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26 Week, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Single Intra-Articular Injection 1.2% Sodium Hyaluronate for Treatment of Painful Osteoarthritis of the Knee, With Optional 26-Week Open-Label Safety Extension
- ClinicalTrials.gov ID
- NCT00988091
- Acronym / sponsor ID
- 2009-03
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Posted 4 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IA-SA | Placebo comparator | Device: Buffered SalineEach participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks. |
| IA-BioHA | Experimental | Device: 1.2% Sodium HyaluronateEach participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chronic osteoarthritis (OA) of target knee confirmed by American College of Rheumatology (ACR) Criteria.
- Pain due to OA in target knee present for at least 6 months.
- During Screening and Baseline visits, subjects will require a visual analog scale (VAS) score (100 mm) of ≥ 41 mm and ≤ 90 mm, recorded immediately following a 50-foot walk, AND at Baseline, cannot have decreased >10mm (improvement) from Screening.
- A bilateral standing anteroposterior (AP) X-ray confirming OA of the target knee.
- Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
Key exclusion criteria (24 listed)
- Any major injury (including sports injuries) to the target knee within the prior 12 months.
- Any surgery to the target knee, hip and contralateral hip within the prior 12 months.
- Major and minor articular procedures
- Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis.
- Gout or calcium pyrophosphate (pseudogout) diseases of the target knee that have flared within the previous 6 months.
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 |
|---|---|---|
| 1.2% Sodium HyaluronateAlso: sodium hyaluronateIA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27). | Device | IA-BioHA |
| Buffered SalineAlso: salineIA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period. | Device | IA-SA |
Primary outcome
Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26
Time frame: Day 0 (baseline) through Week 26
The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.
6 secondary outcomes
Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26
Time frame: Day 0 (baseline), week 26
Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.
Time frame: Day 0 (baseline), Week 26
Subjective Patient Assessment of Treatment at Week 26
Time frame: Week 26
Number of Tablets of Rescue Medication Used Between Visits
Time frame: Day 1 to week 26
Change From Baseline in Patient Global Assessment at Week 26
Time frame: Day 0 (baseline), Week 26
Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26
Time frame: Day 0 (baseline), week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1.2% Sodium Hyaluronate and Buffered Saline in people with Osteoarthritis of the Knee, run by Ferring Pharmaceuticals at 34 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 8 inclusion and 24 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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.
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?
Yes. Results are posted in the registry (first posted 4 Jun 2012). 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 the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26 (time frame: Day 0 (baseline) through Week 26). 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 15 Jun 2012.