26 Week Open Label Study Evaluating Single IA Injection of DUROLANE SJ for Treatment of Osteoarthritis Pain of the Ankle

NCT02627859 | Unknown Phase 4

• 1 other identifier: 13DUR502
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

26 week open label study of treatment with Durolane for OA pain of the ankle

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• AOS pain subscale score

  at 26 weeks

Study Arms (1)

Durolane SJ

EXPERIMENTAL

Durolane SJ intra-articular injection; device

Device: Durolane SJ

Interventions

Durolane SJ DEVICE

1ml single intra-articular injection in ankle

Durolane SJ

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioventus LLC: lead

Study Sites (1)

Providence Health Care

Vancouver, British Columbia, V6Z-2A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alistair Younger, MD

  St. Pauls Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 11, 2015
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)