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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001429448

Enrollment

Registered

2016-10-13

Start date

2016-11-21

Completion date

2017-03-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results