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Completed

NCT Number: NCT03062787

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

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).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 04, Barrie, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)

Device

Intra-articular injection

Other names: Cingal®

Monovisc® (Sodium hyaluronate)

Device

Intra-articular injection

Other names: Monovisc®

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)

    Time frame: 6 weeks post injection

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Secondary outcomes

  1. Compare the maximum pain reduction by treatment arm

    Time frame: 6 weeks post injection

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  2. Compare the time to maximum pain reduction by treatment arm

    Time frame: 6 weeks post injection

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  3. Change in stiffness and physical function

    Time frame: 6 weeks post injection

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  4. Overall change of WOMAC score

    Time frame: 6 weeks post injection

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  5. Time to maximum WOMAC score reduction

    Time frame: 6 weeks post injection

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Sponsors and collaborators

Lead sponsor

Pharmascience Inc.

Industry

Registry information

Official study title

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

Acronym: EEFFEK

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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