Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Monovisc® (Sodium hyaluronate); Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)

• Registration Number: NCT03062787
• Lead Sponsor: Pharmascience Inc.

Brief Summary

It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-04-05
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age > 18 years of age
• Diagnosed with osteoarthritis of the knee
• Candidate for an intra-articular injection (single joint, unilateral) of Monovisc® or Cingal® as part of their routine clinical care and in accordance with the locally approved label

Exclusion Criteria

• Previous intra-articular injection within the last 6 months from enrolment
• Known hypersensitivity to cortico-steroids, hyaluronic acid or any component of Cingal® or Monovisc®
• Infectious, traumatic or neoplasic component of knee pathology
• Surgery of the knee within the last 6 months or scheduled surgery in the next two months from enrolment
• Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned.
• Patients with known bleeding disorders
• Patient currently treated with oral steroids or opioids
• Patients that, in the investigators' opinion, are unlikely to comply with protocol
• Pregnant or nursing women or women who suspect they might be pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monovisc®	Monovisc® (Sodium hyaluronate)	Single 4 ml intra-articular injection of Sodium Hyaluronate
Cingal®	Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)	Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide

Primary Outcome Measures

Name	Time	Method
Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC)	6 weeks post injection	Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Secondary Outcome Measures

Name	Time	Method
Change in stiffness and physical function	6 weeks post injection	Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Overall change of WOMAC score	6 weeks post injection	Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time to maximum WOMAC score reduction	6 weeks post injection	Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Compare the time to maximum pain reduction by treatment arm	6 weeks post injection	Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Compare the maximum pain reduction by treatment arm	6 weeks post injection	Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Trial Locations

Locations (5)

Site 04; 🇨🇦 Barrie, Ontario, Canada

Site 02; 🇨🇦 Kanata, Ontario, Canada

Site 03; 🇨🇦 Hamilton, Ontario, Canada

Site 05; 🇨🇦 Laval, Quebec, Canada

Site 01; 🇨🇦 Quebec City, Quebec, Canada