<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04420091</url>
  </required_header>
  <id_info>
    <org_study_id>CARTIDYSS</org_study_id>
    <nct_id>NCT04420091</nct_id>
  </id_info>
  <brief_title>Hydrolyzed Fish Cartilage Effect on Knee Joint Functionality and Discomfort in Adult Population</brief_title>
  <official_title>Effect of Cartidyss-based Dietary Supplement on Knee Joint Functionality and Discomfort in Adult Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abyss Ingredients</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Artialis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Abyss Ingredients</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an exploratory, non-comparative, multi-centric trial in 30 free-living healthy&#xD;
      male and female subjects with moderate knee joint discomfort and loss of functionality.&#xD;
&#xD;
      The objective of this trial is to determine whether oral administration of Cartidyss, a&#xD;
      concentrated fish cartilage extract, can contribute to the improvement of knee joint&#xD;
      functionality and discomfort in adult population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 patients will be enrolled during a 4-month period in 3 investigational sites and each&#xD;
      patient will undergo 3 visits (V0: Inclusion visit at baseline, V1: Follow-Up Visit after 1&#xD;
      month ± 3 day and V2: End Visit after 3 months ± 5 days).&#xD;
&#xD;
      The primary objective of this trial is to determine whether oral administration of Cartidyss,&#xD;
      a concentrated fish cartilage extract, can contribute to the improvement of knee joint&#xD;
      functionality and discomfort in adult population, using a specific self-administered&#xD;
      questionnaire. The secondary objectives of the study are to evaluate the effect of Cartidyss&#xD;
      on knee function and pain at rest and while walking, with patient global assessment and&#xD;
      quality of life at each time point. The tolerance, compliance, satisfaction, rate of&#xD;
      responder to the supplementation and pain killer's consumption would be also evaluated as&#xD;
      secondary endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Actual">December 17, 2020</completion_date>
  <primary_completion_date type="Actual">December 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation</measure>
    <time_frame>3 months (Day 0, Month 1 and Month 3)</time_frame>
    <description>Changes from baseline to 3 months of Knee injury and Osteoarthritis Outcome Score (KOOS) global score using a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of Cartidyss on knee function after 3 months of supplementation</measure>
    <time_frame>3 months (Day 0, Month 1 and Month 3)</time_frame>
    <description>Changes from baseline to each time points of knee function using the KOOS questionnaire, a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of Cartidyss on knee pain at rest and while walking after 3 months of supplementation</measure>
    <time_frame>3 months (Day 0, Month 1 and Month 3)</time_frame>
    <description>Changes from baseline to each time points. Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by 2 verbal descriptors, one for each symptom extreme.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation</measure>
    <time_frame>3 months (Day 0, Month 1 and Month 3)</time_frame>
    <description>Changes from baseline to each time points. Variation of Visual Analogue Scale for patient global assessment of disease activity The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by one verbal descriptors for Global Assessment of disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation</measure>
    <time_frame>3 months (Day 0, Month 1 and Month 3)</time_frame>
    <description>Changes from baseline to each time points. A global score will be calculated in function of the answers of a Self-administered questionnaire (SF-36). The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the tolerance of Cartidyss after 3 months of supplementation</measure>
    <time_frame>Only Month 1 and Month 3</time_frame>
    <description>Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of System Organ Class (SOC) and Low Level Terms (LLT) using the last version of MedDRA) and drop offs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the compliance of Cartidyss after 3 months of supplementation</measure>
    <time_frame>Only Month 1 and Month 3</time_frame>
    <description>Count the capsules in investigation kits brought back by the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the satisfaction of Cartidyss after 3 months of supplementation</measure>
    <time_frame>Only Month 1 and Month 3</time_frame>
    <description>Changes after supplementation. Self-administered questionnaire using a 5-Likert scale (extremely unsatisfied- unsatisfied- nor unsatisfied nor satisfied- satisfied- extremely satisfied) to evaluate the product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the pain killer's consumption during the 3 months of supplementation</measure>
    <time_frame>Only Month 1 and Month 3</time_frame>
    <description>Changes after supplementation. Count the number of consumed pain killer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the rate of responder to the 3 months supplementation of Cartidyss</measure>
    <time_frame>Only Month 1 and Month 3</time_frame>
    <description>Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to the Outcome Measures in Rheumatology (OMERACT) and the OsteoArthritis Research Society International (OARSI) criteria. Responder criteria for osteoarthritis clinical trials based on the questionnaires describe above.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Knee Discomfort</condition>
  <arm_group>
    <arm_group_label>Cartidyss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cartidyss</intervention_name>
    <description>Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months</description>
    <arm_group_label>Cartidyss</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age limits (see above)&#xD;
&#xD;
          -  Body Mass Index BMI ≤ 35 kg/m2&#xD;
&#xD;
          -  Knee discomfort score at rest over the last 24 hours on the most painful knee&#xD;
             evaluated on VAS (0-100) ≥ 40 at baseline&#xD;
&#xD;
          -  Able to follow the instructions of the study&#xD;
&#xD;
          -  Having signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  related to knee:&#xD;
&#xD;
               -  Recent trauma (&lt; 1 month) of the knee responsible of the symptomatic knee;&#xD;
&#xD;
               -  Concurrent articular disease interfering with the evaluation of knee pain left to&#xD;
                  the Investigator's discretion&#xD;
&#xD;
               -  Prosthesis in the target knee&#xD;
&#xD;
          -  related to treatments:&#xD;
&#xD;
               -  Analgesics to manage knee pain 24 hours before inclusion visit;&#xD;
&#xD;
               -  Corticosteroids injection in the target knee in the last month;&#xD;
&#xD;
               -  Hyaluronan injection in the target knee in the last 6 months;&#xD;
&#xD;
               -  Arthroscopy in the last 6 months&#xD;
&#xD;
               -  Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months;&#xD;
&#xD;
               -  Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement,&#xD;
                  i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya&#xD;
                  unsaponifiables int he last 3 months&#xD;
&#xD;
               -  Contraindications to Cartidyss: hypersensitivity or allergy to the product&#xD;
                  components (fish)&#xD;
&#xD;
               -  Treatments based on strontium ranelate, bisphosphonates, selective&#xD;
                  estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months&#xD;
&#xD;
          -  related to associated diseases :&#xD;
&#xD;
               -  Any severe, uncontrolled and limiting diseases left to the Investigator's&#xD;
                  discretion&#xD;
&#xD;
               -  Anticipated need for any surgical or other invasive procedure during the trial&#xD;
                  including prosthesis in the target knee&#xD;
&#xD;
               -  Anticipated need for any forbidden treatments during the trial&#xD;
&#xD;
               -  Swallowing disorder&#xD;
&#xD;
               -  Patient with widespread pain/depression (e.g. fibromyalgia)&#xD;
&#xD;
          -  related to patients:&#xD;
&#xD;
               -  Close collaborators to the investigational team, the study coordinator or to the&#xD;
                  Sponsor&#xD;
&#xD;
               -  Currently participating or having participated in another therapeutic clinical&#xD;
                  trial in the last 3 months&#xD;
&#xD;
               -  Under guardianship or judicial protection&#xD;
&#xD;
               -  Pregnancy, breastfeeding, planned conception, or premenopausal women without&#xD;
                  effective contraception (pill, patch, ring, diaphragm, implant and intrauterine&#xD;
                  device), tubal ligation or hysterectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Chapelle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Médical Chant d'Oiseau (WOLUWÉ-SAINT-PIERRE)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre medical Chant d'Oiseau</name>
      <address>
        <city>Woluwe-Saint-Pierre</city>
        <state>Bruxelles</state>
        <zip>1150</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Princesse Paola, VIVALIA</name>
      <address>
        <city>Marche-en-Famenne</city>
        <zip>6900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee discomfort</keyword>
  <keyword>hydrolyzed fish cartilage</keyword>
  <keyword>food supplement</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04420091
org study id: CARTIDYSS
nct id: NCT04420091
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is an exploratory, non-comparative, multi-centric trial in 30 free-living healthy
      male and female subjects with moderate knee joint discomfort and loss of functionality.

      The objective of this trial is to determine whether oral administration of Cartidyss, a
      concentrated fish cartilage extract, can contribute to the improvement of knee joint
      functionality and discomfort in adult population
30 patients will be enrolled during a 4-month period in 3 investigational sites and each
      patient will undergo 3 visits (V0: Inclusion visit at baseline, V1: Follow-Up Visit after 1
      month ± 3 day and V2: End Visit after 3 months ± 5 days).

      The primary objective of this trial is to determine whether oral administration of Cartidyss,
      a concentrated fish cartilage extract, can contribute to the improvement of knee joint
      functionality and discomfort in adult population, using a specific self-administered
      questionnaire. The secondary objectives of the study are to evaluate the effect of Cartidyss
      on knee function and pain at rest and while walking, with patient global assessment and
      quality of life at each time point. The tolerance, compliance, satisfaction, rate of
      responder to the supplementation and pain killer's consumption would be also evaluated as
      secondary endpoints.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation
time frame: 3 months (Day 0, Month 1 and Month 3)
description: Changes from baseline to 3 months of Knee injury and Osteoarthritis Outcome Score (KOOS) global score using a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.
measure: Evaluate the effect of Cartidyss on knee function after 3 months of supplementation
time frame: 3 months (Day 0, Month 1 and Month 3)
description: Changes from baseline to each time points of knee function using the KOOS questionnaire, a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.
measure: Evaluate the effect of Cartidyss on knee pain at rest and while walking after 3 months of supplementation
time frame: 3 months (Day 0, Month 1 and Month 3)
description: Changes from baseline to each time points. Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by 2 verbal descriptors, one for each symptom extreme.
measure: Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation
time frame: 3 months (Day 0, Month 1 and Month 3)
description: Changes from baseline to each time points. Variation of Visual Analogue Scale for patient global assessment of disease activity The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by one verbal descriptors for Global Assessment of disease activity.
measure: Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation
time frame: 3 months (Day 0, Month 1 and Month 3)
description: Changes from baseline to each time points. A global score will be calculated in function of the answers of a Self-administered questionnaire (SF-36). The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
measure: Evaluate the tolerance of Cartidyss after 3 months of supplementation
time frame: Only Month 1 and Month 3
description: Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of System Organ Class (SOC) and Low Level Terms (LLT) using the last version of MedDRA) and drop offs
measure: Evaluate the compliance of Cartidyss after 3 months of supplementation
time frame: Only Month 1 and Month 3
description: Count the capsules in investigation kits brought back by the patient.
measure: Evaluate the satisfaction of Cartidyss after 3 months of supplementation
time frame: Only Month 1 and Month 3
description: Changes after supplementation. Self-administered questionnaire using a 5-Likert scale (extremely unsatisfied- unsatisfied- nor unsatisfied nor satisfied- satisfied- extremely satisfied) to evaluate the product.
measure: Evaluate the pain killer's consumption during the 3 months of supplementation
time frame: Only Month 1 and Month 3
description: Changes after supplementation. Count the number of consumed pain killer
measure: Evaluate the rate of responder to the 3 months supplementation of Cartidyss
time frame: Only Month 1 and Month 3
description: Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to the Outcome Measures in Rheumatology (OMERACT) and the OsteoArthritis Research Society International (OARSI) criteria. Responder criteria for osteoarthritis clinical trials based on the questionnaires describe above.
arm group label: Cartidyss
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Cartidyss
description: Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months
arm group label: Cartidyss
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Chapelle, MD
role: Principal Investigator
affiliation: Centre Médical Chant d'Oiseau (WOLUWÉ-SAINT-PIERRE)
facility: 
facility: 
country: Belgium
responsible party type: Sponsor