Efficacy and safety of a single injection of Articul One in comparison with Synvisc-One Registered Trademark or placebo for the treatment of symptomatic primary knee osteoarthritis.
A randomised, double-blind using blinded evaluator, placebo and active controlled, pilot study to evaluate the safety and efficacy of intra articular administration of Articul One in patient with symptomatic primary knee osteoarthritis
Clinical Network Services (CNS) Pty Ltd
30 participants
Nov 21, 2016
Interventional
Conditions
Summary
This study aims to investigate the effectiveness and safety of a single intraarticular injection of Articul One in comparison with Synvisc-One Registered Trademark or placebo for the treatment of symptomatic primary knee osteoarthritis. 30 subjects will be randomized to receive either Articul one , the experimental arm (20 subjects), Synvisc-One Registered Trademark, the active comparator arm (5 subjects), or Placebo (5 subjects). This will be done by analysing questionnaires to understand the severity of the disease status, pain and rescue medication diary, and side effects. Safety will be monitored during the treatment visits using standard measures, including physical exams, vital signs (including oral temperature), and side effect monitoring. Subjects may be eligible to join this study if they are aged over 40 years, have knee pain due to osteoarthritis of the knee and are in otherwise general good health. This study will investigate a single dose of Articul One in comparison with Synvisc-One Registered Trademark or placebo (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means the subject and the assessing doctor, together with the study staff will not know whether the subject is receiving Articul One, Synvisc-One Registered Trademark or placebo. The person who administers the injection will be unblinded (they will know what treatment the subject will receive) however, they will not allow the subject or the assessing team know which treatment is being received. The study includes a screening visit (visit 1) to check eligibility and to explain the study.. There will be 1 treatment visit (visit 2) which will occur within 21 days of visit 1. There will also be 4 further visits to assess the safety and effectiveness of the treatment. These visits will occur at weeks 4, 12, 20 and 26. During the follow up period, four clinic visits are required for: review of diary, medications, AEs;. Participants will record rescue pain medication in a daily diary.
Eligibility
Inclusion Criteria5
- Provided written informed consent
- Evidence of grade II or III OA (Kellergan-Lawrence scale) on X-ray
- Has documented diagnosis of symptomatic primary osteoarthritis of the study knee made at least 3 months prior to Screening.
- Has continued study knee osteoarthritis pain despite conservative treatment (e.g., weight reduction, physical therapy, analgesics).
- Is ambulatory with an active lifestyle and in good general health.
Exclusion Criteria4
- Had arthroplasty at the study knee at any time or any other previous surgery in the study knee within the 6 months prior to Screening, or planned surgery throughout the duration of the study.
- History of septic arthritis in any joint.
- Concomitant inflammatory disease or other condition that affects the joints.
- Any known contraindication to paracetamol.
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Interventions
Product: Articul One Dosage form: pre-filled syringe Presentation: Blister containing 3mL syringe enclosed with rubber stoppers and 23G, 1" disposable needle, prefilled with 3mL of formulation as described below. Route of Administration: Single Intra-articular injection Formulation: Ingredient 1: Sodium hyaluronate (60mg) Ingredient 2: Sodium dihydrogen phosphate dehydrate (1.2mg) Ingredient 3: Disodium hydrogen phosphate dehydrate (3.6mg) Ingredient 4: Sodium Chloride (24.9mg) Injection will be performed by qualified medical doctors who will be defined as Sub-Investigators in the study. The medical doctors in this study are specialists in pain management. During the washout period (up to 21 days), participants will be asked to discontinue their anti-inflammatory agents (e.g., NSAIDs) and other analgesics prior to the Baseline Period. Only paracetamol (not more than 4 grams per day) will be allowed as rescue medication and this cannot be used within 48 hours of any site visits.
Locations(1)
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ACTRN12616001429448