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

Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study)

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide); Device: Monovisc® (Sodium hyaluronate)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada
      • Site 04
    • Hamilton, Ontario, Canada
      • Site 03
    • Kanata, Ontario, Canada
      • Site 02
  • Quebec
    • Laval, Quebec, Canada
      • Site 05
    • Quebec City, Quebec, Canada
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cingal®; Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide	Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide); Intra-articular injection; Other Names: Cingal®
Active Comparator: Monovisc®; Single 4 ml intra-articular injection of Sodium Hyaluronate	Device: Monovisc® (Sodium hyaluronate); Intra-articular injection; Other Names: Monovisc®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	6 weeks post injection

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pharmascience Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Hyaluronic Acid
• Other Study ID Numbers: CIN-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No