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出境医 / 临床实验 / Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis

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

Study Description
Brief 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 provide a better clinical outcome to the patient.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Gonarthrosis Drug: Collagen-PVP Device: Hylan G-F 20 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: Double-blind masking.
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Collagen-PVP
Collagen-polyvinyl pyrrolidone (collagen-PVP).
 Drug: Collagen-PVP
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)
Other Name: Fibroquel
Active Comparator: Hylan G-F 20
Hylan G-F 20.
 Device: Hylan G-F 20
Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
Other Name: Synvisc
Outcome Measures
Primary Outcome Measures :
  1. International Knee Documentation Committee (IKDC). [ Time Frame: Evaluation will be conducted at Baseline and 6 months after first infiltration ]
    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.


Secondary Outcome Measures :
  1. Change in Pain Intensity [ Time Frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration ]
    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

  2. Change in quality of life: EQS-5D [ Time Frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration ]
    Change from Baseline in quality of life (EQS-5D) score at 6 months.

  3. Changes in Urine Collagen Type II C-telopeptide Fragments [ Time Frame: Evaluation will be conducted at Baseline, and 6 months after first infiltration ]
    Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gabriel J Horta-Baas, MD, Msc 529998360846 gabho@hotmail.com
Contact: Maria Romero-Figueroa, MD, PhD sromero61@hotmail.com

Locations
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Mexico
Gabriel Horta Baas Recruiting
Merida, Yucatan, Mexico, 97000
Contact: Gabriel J Horta Baas, MD, Msc    529993860846    gabho@hotmail.com   
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 17, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		International Knee Documentation Committee (IKDC). [ Time Frame: Evaluation will be conducted at Baseline and 6 months after first infiltration ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019) 		International Knee Documentation Committee (IKDC) [ Time Frame: Evaluation will be conducted at Baseline and 6 months after first infiltration ]
Change from Baseline in International Knee Documentation Committee (IKDC) subjective score at 6 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Change in Pain Intensity [ Time Frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration ]
    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
  • Change in quality of life: EQS-5D [ Time Frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration ]
    Change from Baseline in quality of life (EQS-5D) score at 6 months.
  • Changes in Urine Collagen Type II C-telopeptide Fragments [ Time Frame: Evaluation will be conducted at Baseline, and 6 months after first infiltration ]
    Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Change in Pain Intensity [ Time Frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration ]
    Change from Baseline in Pain Intensity score (MOS Pain severity scale) at 6 months.
  • Change in quality of life: EQS-5D [ Time Frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration ]
    Change from Baseline in quality of life (EQS-5D) score at 6 months.
  • Changes in Urine Collagen Type II C-telopeptide Fragments [ Time Frame: Evaluation will be conducted at Baseline, and 6 months after first infiltration ]
    Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis
Official Title  ICMJE 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
Brief 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 provide a better clinical outcome to the patient.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description:
Double-blind masking.
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Gonarthrosis
Intervention  ICMJE
  • Drug: Collagen-PVP
    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)
    Other Name: Fibroquel
  • Device: Hylan G-F 20
    Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
    Other Name: Synvisc
Study Arms  ICMJE
  • Experimental: Collagen-PVP
    Collagen-polyvinyl pyrrolidone (collagen-PVP).
    Intervention: Drug: Collagen-PVP
  • Active Comparator: Hylan G-F 20
    Hylan G-F 20.
    Intervention: Device: Hylan G-F 20
Publications *
  • Furuzawa-Carballeda J, Muñoz-Chablé OA, Barrios-Payán J, Hernández-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.
  • Furuzawa-Carballeda J, Muñoz-Chablé OA, Macías-Hernández 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.
  • Furuzawa-Carballeda J, Lima G, Llorente L, Nuñez-Álvarez C, Ruiz-Ordaz BH, Echevarría-Zuno S, Hernández-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabriel J Horta-Baas, MD, Msc 529998360846 gabho@hotmail.com
Contact: Maria Romero-Figueroa, MD, PhD sromero61@hotmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019782
Other Study ID Numbers  ICMJE R-2018-785-041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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