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Knee OsteoarthritisPhase 3NCT04019782

Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis

A Phase 3 study testing Collagen-PVP and Hylan G-F 20 in people with Knee Osteoarthritis and Gonarthrosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Knee Osteoarthritis, Gonarthrosis
What is being tested?
Collagen-PVP and Hylan G-F 20
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteMexico
Study dates
1 Aug 2019to 31 Aug 2021
Phase
Phase 3
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 40 and 80 years old
  • Osteoarthritis in the knee rated II or III (Kellgren-Lawrence Grading Scale).
  • Pain intensity (MOS Pain Severity Scale) greater than 40.
  • Subject able to understand, co-operative and reliable.
  • Written informed consent.

Who cannot join

  • Acute arthritis in the knee.
  • Ongoing anticoagulant therapy.
  • Skin infection at the injection site.
  • Systemic or intraarticular (target knee) corticosteroids in the past 3 months.
  • Viscosupplementation (target knee) in the past year
  • Arthroscopy/osteotomy/surgery in the past 5 months (target knee).
Show all 12Show fewer
  • Any surgery scheduled in the next 6 months
  • Concomitant rheumatic disease (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, fibromyalgia).
  • Severe varus/valgus deformity (>15°).
  • Frontal deformity greater than 20 degrees
  • History of allergy or hypersensitivity to hyaluronic acid or avian proteins
  • History/present evidence of: metabolic joint diseases; crystal arthropaties; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders.

Trial locations and contacts

1 site in 1 country.

Gabriel J Horta-Baas, MD, Msc contact

529998360846

gabho@hotmail.com

Maria Romero-Figueroa, MD, PhD contact

sromero61@hotmail.com

Mexico1 site, 1 recruiting

  • Gabriel Horta Baas

    Mérida, Yucatán, 97000

    Gabriel J Horta Baas, MD, Msc, 529993860846, gabho@hotmail.com

    Recruiting

Other trials in Mexico

About this study

Official title: Efficacy Evaluation of Intraarticular Collagen-polyvinyl Pyrrolidone (Fibroquel®) vs Hylan G-F 20 (Synvisc®) in the Treatment of Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study

Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and provide a better clinical outcome to the patient.

Read the detailed description

This study aims to compare effectiveness of the treatment with intra-articular administration of collagen-PVP versus hylan GF 20, using the International Knee Documentation Committee (IKDC) score, 6 months after treatment. Hypothesis to test is: If effectiveness of intra-articular collagen-PVP is not lower than hylan GF 20 treatment in knee osteoarthritis subjects, then, statistically significant difference would not exist in IKDC score mean increase among treatment groups, after six months.

Being tested
Collagen-PVP, Hylan G-F 20
Keywords
Osteoarthritis, Intraarticular Injections, Viscosupplementations, Type I Collagen, Patient Outcome Assessment, Patient Reported Outcome Measures
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Osteogenesis Imperfecta, Type IV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collagen-PVPDrug

    Also called Fibroquel

    Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days)

  • Hylan G-F 20Device

    Also called Synvisc

    Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)

Study groups in NCT04019782
Study groupRoleWhat they receive
Collagen-PVPExperimentalCollagen-polyvinyl pyrrolidone (collagen-PVP).
Receives: Drug: Collagen-PVP
Hylan G-F 20Active comparatorHylan G-F 20.
Receives: Device: Hylan G-F 20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Knee Documentation Committee (IKDC).

    Change from Baseline in International Knee Documentation Committee (IKDC) subjective score at 6 months. The IKDC subjetive form is a patient-reported outcome, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).The IKDC is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (add the score for each item and divide by the maximum possible). The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.

    Measured: Evaluation will be conducted at Baseline and 6 months after first infiltration

Secondary outcomes (3)

  1. Change in Pain Intensity

    Change from Baseline in Pain Intensity score (MOS Pain severity scale) at 6 months. The Medical Outcomes Study (MOS) Pain Severity Scale is a 5-item scale to assess pain intensity (average and at the most), frequency, and duration over the last 7 days. Scores range from 0-100; higher score indicates more pain

    Measured: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration

  2. Change in quality of life: EQS-5D

    Change from Baseline in quality of life (EQS-5D) score at 6 months.

    Measured: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration

  3. Changes in Urine Collagen Type II C-telopeptide Fragments

    Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months

    Measured: Evaluation will be conducted at Baseline, and 6 months after first infiltration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start1 Aug 2019 (estimated)
  3. Primary completion28 Feb 2021 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants in one group receive drug A (Hylan G-F20) "in parallel" to participants in the other group, who receive drug B (Collagen-PVP).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04019782
Sponsor's protocol ID
R-2018-785-041
Status last verified
Jul 2019
First submitted
11 Jul 2019
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Furuzawa-Carballeda J, Munoz-Chable OA, Barrios-Payan J, Hernandez-Pando R. Effect of polymerized-type I collagen in knee osteoarthritis. I. In vitro study. Eur J Clin Invest. 2009 Jul;39(7):591-7. doi: 10.1111/j.1365-2362.2009.02154.x.

    PubMed 19453649

  • Furuzawa-Carballeda J, Munoz-Chable OA, Macias-Hernandez SI, Agualimpia-Janning A. Effect of polymerized-type I collagen in knee osteoarthritis. II. In vivo study. Eur J Clin Invest. 2009 Jul;39(7):598-606. doi: 10.1111/j.1365-2362.2009.02144.x. Epub 2009 Apr 23.

    PubMed 19397687

  • Furuzawa-Carballeda J, Lima G, Llorente L, Nunez-Alvarez C, Ruiz-Ordaz BH, Echevarria-Zuno S, Hernandez-Cuevas V. Polymerized-type I collagen downregulates inflammation and improves clinical outcomes in patients with symptomatic knee osteoarthritis following arthroscopic lavage: a randomized, double-blind, and placebo-controlled clinical trial. ScientificWorldJournal. 2012;2012:342854. doi: 10.1100/2012/342854. Epub 2012 Apr 1.

    PubMed 22545014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Collagen-PVP and Hylan G-F 20 in people with Knee Osteoarthritis and Gonarthrosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gabriel J Horta-Baas, MD, Msc (529998360846, gabho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Knee Documentation Committee (IKDC). (time frame: Evaluation will be conducted at Baseline and 6 months after first infiltration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019782, which also lists 3 linked publications.

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 17 Jul 2019.

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