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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)
Monovisc® (Sodium hyaluronate)
Sponsored by
Pharmascience Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 04
  • Site 03
  • Site 02
  • Site 05
  • Site 01

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cingal®

Monovisc®

Arm Description

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

Single 4 ml intra-articular injection of Sodium Hyaluronate

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2017
Last Updated
April 17, 2020
Sponsor
Pharmascience Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03062787
Brief Title
Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee
Acronym
EEFFEK
Official Title
Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmascience Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cingal®
Arm Type
Experimental
Arm Description
Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide
Arm Title
Monovisc®
Arm Type
Active Comparator
Arm Description
Single 4 ml intra-articular injection of Sodium Hyaluronate
Intervention Type
Device
Intervention Name(s)
Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)
Other Intervention Name(s)
Cingal®
Intervention Description
Intra-articular injection
Intervention Type
Device
Intervention Name(s)
Monovisc® (Sodium hyaluronate)
Other Intervention Name(s)
Monovisc®
Intervention Description
Intra-articular injection
Primary Outcome Measure Information:
Title
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)
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
6 weeks post injection
Secondary Outcome Measure Information:
Title
Compare the maximum pain reduction by treatment arm
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
6 weeks post injection
Title
Compare the time to maximum pain reduction by treatment arm
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
6 weeks post injection
Title
Change in stiffness and physical function
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
6 weeks post injection
Title
Overall change of WOMAC score
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
6 weeks post injection
Title
Time to maximum WOMAC score reduction
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
6 weeks post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 04
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Site 03
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Site 02
City
Kanata
State/Province
Ontario
Country
Canada
Facility Name
Site 05
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Site 01
City
Quebec City
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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