OsteoarthritisPhase 4NCT02627859
26 Week Open Label Study Evaluating Single IA Injection of DUROLANE SJ for Treatment of Osteoarthritis Pain of the Ankle
A Phase 4 study testing Durolane SJ in people with Osteoarthritis, run by Bioventus LLC at 1 site in Canada.
Trial summary
26 week open label study of treatment with Durolane for OA pain of the ankle Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Durolane SJ
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Oct 2016
- Phase
- Phase 4
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females or males between the ages of 19 and 85 years of age
- Diagnosis of mild to moderate (K-L grade II or III) osteoarthritis (OA) of the study ankle joint, confirmed by radiographs taken within the previous six months OA in the contralateral ankle is permissible provided that OA symptoms are greater in the study ankle.
- VAS (100mm) AOS pain subscale score in the range of 30mm to 90mm for the study ankle
- Must be willing to discontinue use of oral and topical analgesia other than rescue use of acetaminophen for any pain including OA pain in the study ankle. Must also be willing to discontinue acetaminophen rescue medication for at least 24 hours before each study visit
- Abstinence from any IA or peri-articular injections in the study ankle during the course of the trial, except for the Investigational Product
- Cooperative and able to communicate effectively with the Investigators
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- Patients with chronic ankle pain of the study ankle lasting more than 6 months without clinically significant improvement in ankle pain over the past one month
- Body mass index (BMI) ≤ 35 kg/m2.
- English literacy and ability to understand and complete all informed consent procedures
Who cannot join
- Significant pain from other joints or low back pain requiring chronic ongoing analgesic therapy
- Hindfoot deformities
- Substantial venous or lymphatic stasis in the legs
- Presence of one or more conditions that could confound pain and functional assessments in the study ankle, e.g., plantar fasciitis, Achilles tendonitis, sprains of the foot, or degenerative joint disease of the foot.
- Clinically-apparent tense effusion, signs of misalignment or instability in the study ankle
- Ankle x-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity in the study ankle
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- Surgery to the study ankle within the previous 12 months
- Unable to abstain treatment with NSAIDs or any pain management medications during the week (or five half-lives of the drug, whichever is longer) prior to Baseline Visit.
- Unable to abstain from treatment with topical analgesics during the washout period prior to screening visit and throughout the duration of the study. Washout period for topical analgesics is based on clinical investigator judgment (~ a few days).
- Inability to tolerate acetaminophen for rescue medication use.
- IA or local peri-articular corticosteroid injections to the study ankle within the previous three months; or to any other joint within the previous month; or any oral corticosteroid within the previous month. Steroid inhalants are permitted if the patient has been on a stable regimen for the past month and remains on this regimen throughout the course of the trial
- IA injections with hyaluronic acid in the study ankle within the last 9 months
- Previous allergic reaction to a HA or lidocaine product allergies.
- Treatment with glucosamine/chondroitin sulfate initiated within the past three months, or dosage not stable for the past three months
- Change in physical therapy for the study ankle within one month preceding screening, or expected change in physical therapy for the ankle during the study
- Planned surgical procedure during the study period.
- Previous history or presence of septic arthritis in study ankle
- Active skin disease or infection in the area of the injection site
- Alcohol or drug abuse as determined by the Investigator or use of alcohol for control of pain; Use of illicit drugs including cannabis.
- Systemic inflammatory condition or autoimmune disease or infection such as rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, gout/ acute pseudo gout or any other connective tissue disease
- Uncontrolled hypothyroidism
- Treatment with anticoagulant (except for acetylsalicylic acid maximum of 325mg/day)
- Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia)
- Pregnant or breast-feeding woman or woman of child-bearing potential not practicing adequate contraception.
- Subjects that in the opinion of the investigator are unsuitable for inclusion (e.g., subjects not likely to avoid other therapies, subjects not likely to stay in the study or with plans to relocate during the whole study period, or subjects likely to be unreliable)
- Concurrent participation in any other clinical study or participation within the preceding 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 26 Week Multicenter Prospective Open Label Clinical Study Evaluating a Single Intra-articular Injection of DUROLANE SJ1ml for Treatment of OA Pain of the Ankle
26 week open label study of treatment with Durolane for OA pain of the ankle
Read the detailed description
Single injection Durolane in patients with mild to moderate OA of the ankle.
- Conditions
- Osteoarthritis
- Being tested
- Durolane SJ
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durolane SJDevice
1ml single intra-articular injection in ankle
| Study group | Role | What they receive |
|---|---|---|
| Durolane SJ | Experimental | Durolane SJ intra-articular injection; device Receives: Device: Durolane SJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOS pain subscale score
Measured: at 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 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alistair Younger, MD, Principal investigator, St. Pauls Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627859
- Sponsor's protocol ID
- 13DUR502
- Status last verified
- Sep 2016
- First submitted
- 8 Dec 2015
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26 Week Multicenter Prospective Open Label Clinical Study Evaluating a Single Intra-articular Injection of DUROLANE SJ1ml for Treatment of OA Pain of the Ankle
- ClinicalTrials.gov ID
- NCT02627859
- Acronym / sponsor ID
- 13DUR502
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 11 Dec 2015 (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.
26 week open label study of treatment with Durolane for OA pain of the ankle
Detailed description
Single injection Durolane in patients with mild to moderate OA of the ankle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durolane SJ | Experimental | Device: Durolane SJDurolane SJ intra-articular injection; device |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females or males between the ages of 19 and 85 years of age
- Diagnosis of mild to moderate (K-L grade II or III) osteoarthritis (OA) of the study ankle joint, confirmed by radiographs taken within the previous six months OA in the contralateral ankle is permissible provided that OA symptoms are greater in the study ankle.
- VAS (100mm) AOS pain subscale score in the range of 30mm to 90mm for the study ankle
- Must be willing to discontinue use of oral and topical analgesia other than rescue use of acetaminophen for any pain including OA pain in the study ankle. Must also be willing to discontinue acetaminophen rescue medication for at least 24 hours before each study visit
- Abstinence from any IA or peri-articular injections in the study ankle during the course of the trial, except for the Investigational Product
Key exclusion criteria (26 listed)
- Significant pain from other joints or low back pain requiring chronic ongoing analgesic therapy
- Hindfoot deformities
- Substantial venous or lymphatic stasis in the legs
- Presence of one or more conditions that could confound pain and functional assessments in the study ankle, e.g., plantar fasciitis, Achilles tendonitis, sprains of the foot, or degenerative joint disease of the foot.
- Clinically-apparent tense effusion, signs of misalignment or instability in the study ankle
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 |
|---|---|---|
| Durolane SJ1ml single intra-articular injection in ankle | Device | Durolane SJ |
Primary outcome
AOS pain subscale score
Time frame: at 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Individual participant dataSharing planned: Yes
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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.
Alistair Younger, MD principal investigator
St. Pauls Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Durolane SJ in people with Osteoarthritis, run by Bioventus LLC at 1 site in Canada.
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 9 inclusion and 26 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
AOS pain subscale score (time frame: at 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 21 Sep 2016.