Osteoarthritis, KneeEEFFEKNCT03062787
Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee
A study testing Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) and Monovisc® (Sodium hyaluronate) in people with Osteoarthritis, Knee, run by Pharmascience Inc. at 5 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) and Monovisc® (Sodium hyaluronate)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesCanada
- Study dates
- 5 Apr 2017to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Site 04
Barrie, Ontario
Site 03
Hamilton, Ontario
Site 02
Kanata, Ontario
Site 05
Laval, Quebec
Site 01
Québec, Quebec
About this study
Official title: 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).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide), Monovisc® (Sodium hyaluronate)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)Device
Also called Cingal®
Intra-articular injection
Monovisc® (Sodium hyaluronate)Device
Also called Monovisc®
Intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Cingal® | Experimental | Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide Receives: Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) |
| Monovisc® | Active comparator | Single 4 ml intra-articular injection of Sodium Hyaluronate Receives: Device: Monovisc® (Sodium hyaluronate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks post injection
Secondary outcomes (5)
Compare the maximum pain reduction by treatment arm
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 6 weeks post injection
Compare the time to maximum pain reduction by treatment arm
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 6 weeks post injection
Change in stiffness and physical function
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 6 weeks post injection
Overall change of WOMAC score
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 6 weeks post injection
Time to maximum WOMAC score reduction
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 6 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start5 Apr 2017
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmascience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062787
- Sponsor's protocol ID
- CIN-401
- Acronym
- EEFFEK
- Status last verified
- Apr 2020
- First submitted
- 13 Feb 2017
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study)
- ClinicalTrials.gov ID
- NCT03062787
- Acronym / sponsor ID
- EEFFEK / CIN-401
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pharmascience Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cingal® | Experimental | Device: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide |
| Monovisc® | Active comparator | Device: Monovisc® (Sodium hyaluronate)Single 4 ml intra-articular injection of Sodium Hyaluronate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)Also: Cingal®Intra-articular injection | Device | Cingal® |
| Monovisc® (Sodium hyaluronate)Also: Monovisc®Intra-articular injection | Device | Monovisc® |
Primary outcome
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)
5 secondary outcomes
Compare the maximum pain reduction by treatment arm
Time frame: 6 weeks post injection
Compare the time to maximum pain reduction by treatment arm
Time frame: 6 weeks post injection
Change in stiffness and physical function
Time frame: 6 weeks post injection
Overall change of WOMAC score
Time frame: 6 weeks post injection
Time to maximum WOMAC score reduction
Time frame: 6 weeks post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Bhandari, MD, PhD principal investigator
McMaster University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) and Monovisc® (Sodium hyaluronate) in people with Osteoarthritis, Knee, run by Pharmascience Inc. at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.