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

Osteoarthritis, Knee Clinical Trial

— EEFFEK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062787
• Other study ID #: CIN-401
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: October 25, 2017

Study information

• Verified date: April 2020
• Source: Pharmascience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)
Intra-articular injection
• Monovisc® (Sodium hyaluronate)
Intra-articular injection

Locations

Country	Name	City	State
Canada	Site 04	Barrie	Ontario
Canada	Site 03	Hamilton	Ontario
Canada	Site 02	Kanata	Ontario
Canada	Site 05	Laval	Quebec
Canada	Site 01	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Pharmascience Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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