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

NCT03062787 | Completed

• 1 other identifier: CIN-401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Compare the maximum pain reduction by treatment arm

  6 weeks post injection

• Compare the time to maximum pain reduction by treatment arm

  6 weeks post injection

• Change in stiffness and physical function

  6 weeks post injection

• Overall change of WOMAC score

  6 weeks post injection

• Time to maximum WOMAC score reduction

  6 weeks post injection

Study Arms (2)

Cingal®

EXPERIMENTAL

Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide

Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)

Monovisc®

ACTIVE COMPARATOR

Single 4 ml intra-articular injection of Sodium Hyaluronate

Device: Monovisc® (Sodium hyaluronate)

Interventions

Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) DEVICE

Intra-articular injection

Also known as: Cingal®

Cingal®

Monovisc® (Sodium hyaluronate) DEVICE

Intra-articular injection

Also known as: Monovisc®

Monovisc®

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmascience Inc.: lead

Study Sites (5)

Site 04

Barrie, Ontario, Canada

Location

Site 03

Hamilton, Ontario, Canada

Location

Site 02

Kanata, Ontario, Canada

Location

Site 05

Laval, Quebec, Canada

Location

Site 01

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mohit Bhandari, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: April 5, 2017
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)