26 Week Open Label Study Evaluating Single IA Injection of DUROLANE SJ for Treatment of Osteoarthritis Pain of the Ankle
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Durolane SJ
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Providence Health Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Durolane SJ
Arm Description
Durolane SJ intra-articular injection; device
Outcomes
Primary Outcome Measures
AOS pain subscale score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02627859
Brief Title
26 Week Open Label Study Evaluating Single IA Injection of DUROLANE SJ for Treatment of Osteoarthritis Pain of the Ankle
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioventus LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durolane SJ
Arm Type
Experimental
Arm Description
Durolane SJ intra-articular injection; device
Intervention Type
Device
Intervention Name(s)
Durolane SJ
Intervention Description
1ml single intra-articular injection in ankle
Primary Outcome Measure Information:
Title
AOS pain subscale score
Time Frame
at 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alistair Younger, MD
Organizational Affiliation
St. Pauls Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Health Care
City
Vancouver,
State/Province
British Columbia
ZIP/Postal Code
V6Z-2A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
26 Week Open Label Study Evaluating Single IA Injection of DUROLANE SJ for Treatment of Osteoarthritis Pain of the Ankle
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