Knee OsteoarthritisNCT01753830
Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis
A study testing Durolane and PBS in people with Knee Osteoarthritis, run by Galderma R&D at 25 sites in United States.
Trial summary
The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee. 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?
- Durolane and PBS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 25 sitesUnited States
- Study dates
- Dec 2012to Feb 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≤ 35 kg/m2
- Symptomatic osteoarthritis (OA) of the knee
- K L severity grade 1 or 2
- If bilateral OA, contralateral knee K L severity grade 0 or 1
Who cannot join
- Has clinically apparent tense effusion of the index knee
- Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
- Has any painful orthopedic disorders of the back or hip
- Has a joint disorder other than osteoarthritis in the index knee
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Anniston, Alabama
Study site
Beverly Hills, California
Study site
Boise, Idaho
Study site
Boulder, Colorado
Study site
Charleston, South Carolina
Study site
Danbury, Connecticut
Study site
Duncansville, Pennsylvania
Study site
El Cajon, California
Study site
Evansville, Indiana
Study site
Hot Springs, Arkansas
Study site
Kalamazoo, Michigan
Study site
Lauderdale Lakes, Florida
Study site
Meridian, Idaho
Study site
Mobile, Alabama
Study site
New Orleans, Louisiana
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
South Miami, Florida
Study site
Springfield, Missouri
Study site
Trumbull, Connecticut
Study site
Tucson, Arizona
Study site
Wheaton, Maryland
Study site
Wyomissing, Pennsylvania
About this study
Official title: A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee
The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- Durolane, PBS
- Keywords
- Double-blind, Randomized, Intraarticular injection, Hyaluronic acid, Placebo, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurolaneDevice
4.5 mL
PBSDevice
4.5 mL
| Study group | Role | What they receive |
|---|---|---|
| Durolane | Experimental | Single intraarticular injection of Durolane Receives: Device: Durolane |
| PBS | Placebo comparator | Single intraarticular injection of PBS Receives: Device: PBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Study terminated early due to decision by sponsor
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nebojsa Skrepnik, MD, PhD, Principal investigator, Tucson Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753830
- Sponsor's protocol ID
- 35GA1203
- Status last verified
- Sep 2020
- First submitted
- 12 Dec 2012
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01753830
- Acronym / sponsor ID
- 35GA1203
- Conditions
- Knee Osteoarthritis
- Keywords
- Double-blind, Randomized, Intraarticular injection, Hyaluronic acid, Placebo, Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to decision by sponsor
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 30 Sep 2020
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 the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with 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 |
|---|---|---|
| Durolane | Experimental | Device: DurolaneSingle intraarticular injection of Durolane |
| PBS | Placebo comparator | Device: PBSSingle intraarticular injection of PBS |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) ≤ 35 kg/m2
- Symptomatic osteoarthritis (OA) of the knee
- K L severity grade 1 or 2
- If bilateral OA, contralateral knee K L severity grade 0 or 1
Key exclusion criteria (4 listed)
- Has clinically apparent tense effusion of the index knee
- Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
- Has any painful orthopedic disorders of the back or hip
- Has a joint disorder other than osteoarthritis in the index knee
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 |
|---|---|---|
| Durolane4.5 mL | Device | Durolane |
| PBS4.5 mL | Device | PBS |
Primary outcome
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
Time frame: Up to 30 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nebojsa Skrepnik, MD, PhD principal investigator
Tucson Orthopaedic Institute
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Durolane and PBS in people with Knee Osteoarthritis, run by Galderma R&D at 25 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
Yes. Results are posted in the registry (first posted 30 Sep 2020). 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?
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 (time frame: Up to 30 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 26 Aug 2022.