Knee OsteoarthritisPhase 4NACSKONCT03731793
Efficacy of Non-animal Chondroitin Sulphate for Overweight Subjects With Knee Ostoarthritis.
A Phase 4 study testing Non-Animal Chondroitin Sulphate in people with Knee Osteoarthritis, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
Knee osteoarthritis (OA) is predicted to become the fourth leading cause of disability worldwide by 2020. and is estimated to affect more than 40 million people in Europe and 4 million people in Italy. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Non-Animal Chondroitin Sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 20 Oct 2018
- Phase
- Phase 4
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian subjects, males and females, with the following characteristics were included in the trial and randomly assigned to the experimental group (N=30) or a control group (N=30): Individuals overweight (BMI > 25 kg/m2), aged 40-74.; Mobility impairment, joint discomfort or established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA).
Who cannot join
- Anyone with evidence of heart disease, kidney or liver disease, or any other disease that might influence the results of the study was excluded.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Pavia, 27100
About this study
Official title: Efficacy and Safety of Non-animal Chondroitin Sulphate Supplementation in the Treatment of Moderate Knee Osteoarthritis in a Group of Overweight Subjects: a Randomized, Double Blind, Placebo-controlled Study.
Knee osteoarthritis (OA) is predicted to become the fourth leading cause of disability worldwide by 2020. and is estimated to affect more than 40 million people in Europe and 4 million people in Italy. OA has multifactorial etiology and obesity is one of the most important risk factor for knee Regarding therapy of OA in 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a treatment algorithm for the management of knee OA. In Step 1 of the treatment, it is recommended to initiate therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Among SYSADOAs, the evidence is greatest for the effect of chondroitin sulfate (CS).
Sixty overweight subjects with knee osteoarthritis (OA) were recruited and randomly allocated to a group of treatment with 600 mg/d of non-animal Chondroitin sulphate (CS) or to a placebo group.
Read more
These measurements were considered:
Tegner Lysholm Knee Scoring (TLKS), Western Ontario and McMaster Universities Arthritis (WOMAC) index and Visual Analogue Scale (VAS) for pain were analyzed at time 0 and at 4 and 12 weeks. Health-related quality of life by ShortForm36, inflammation by C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were also evaluated, together with a body composition assessment performed by DXA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Non-Animal Chondroitin Sulphate, Placebo
- Keywords
- non-animal chondroitin sulphate, knee osteoarthritis, overweight
- Medical subject headings
- Osteoarthritis, Knee, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Animal Chondroitin SulphateBiological
Mythocondro® is an ichthyic-like chondroitin sulfate produced by chemical sulfation of a non-sulfated chondroitin backbone obtained by thermo-acid hydrolysis of the capsular polysaccharide naturally produced by an Escherichia coli strain.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo. For 90 days one capsule/day. Receives: Other: Placebo |
| Intervention Group | Experimental | 600 mg/day of non-animal Chondroitin Sulphate. One capsule/day for 90 days. Receives: Biological: Non-Animal Chondroitin Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Generic Pain (VAS)
Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain. A VAS reduction is expected only in treatment group.
Measured: 0, 30, 90 days
Change in Knee Pain (WOMAC)
Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations. A significant decrease in expected in treatment group.
Measured: 0, 30, 90 days
Change in Knee Functionality (TLKS)
Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability. An increase in expected in treatment group.
Measured: 0, 30, 90 days
Secondary outcomes (3)
Change in Quality of Life (SF-36)
Health-related quality of life, recorded by the Short Form 36 Health questionnaire (SF-36), a generic measure of health status designed for use in population surveys which consider body pain as a dimension of health status. This is a self-reporting questionnaire and outcomes are measured with 8 numbers that express 8 different aspects of quality of life. Scoring 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the given scoring key. all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
Measured: 0, 30, 90 days
Change in Inflammatory Markers circulating levels (CRP, ESR)
Inflammation markers in plasma: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR). High-Sensitivity CRP was determined by immunonephelometry while the erythrocyte sedimentation rate (ESR) was analyzed by capillary photometry.
Measured: 0, 30, 90 days
Change in total Fat Mass, Total Free Fat Mass and Visceral adipose tissue (DXA)
Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured at baseline by DXA, using a Lunar Prodigy DEXA (GE Medical Systems, Waukesha, WI). Free Fat mass, Fat mass and visceral fat data were derived from DXA using the DXA Prodigy enCORE software (version 17; GE Healthcare).
Measured: 0, 30, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized placebo controlled study. 90 days of treatment with 600 mg/d of non-animal Chondroitin Sulphate or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Gnosis SpA
- Responsible party
- Principal investigator, Mariangela Rondanelli, University of Pavia
- Investigators
- Mariangela Rondanelli, Professor, Study director, IRCCS Mondino Foundation, Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731793
- Sponsor's protocol ID
- 8810/02112017
- Acronym
- NACSKO
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are planned to be available for Gnosis SpA and together with the study pubblication. IPD will be not available for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Non-animal Chondroitin Sulphate Supplementation in the Treatment of Moderate Knee Osteoarthritis in a Group of Overweight Subjects: a Randomized, Double Blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT03731793
- Acronym / sponsor ID
- NACSKO / 8810/02112017
- Conditions
- Knee Osteoarthritis
- Keywords
- non-animal chondroitin sulphate, knee osteoarthritis, overweight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Collaborators
- Gnosis SpA
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 6 Nov 2018 (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.
Knee osteoarthritis (OA) is predicted to become the fourth leading cause of disability worldwide by 2020. and is estimated to affect more than 40 million people in Europe and 4 million people in Italy. OA has multifactorial etiology and obesity is one of the most important risk factor for knee Regarding therapy of OA in 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a treatment algorithm for the management of knee OA. In Step 1 of the treatment, it is recommended to initiate therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Among SYSADOAs, the evidence is greatest for the effect of chondroitin sulfate (CS).
Sixty overweight subjects with knee osteoarthritis (OA) were recruited and randomly allocated to a group of treatment with 600 mg/d of non-animal Chondroitin sulphate (CS) or to a placebo group.
These measurements were considered:
Tegner Lysholm Knee Scoring (TLKS), Western Ontario and McMaster Universities Arthritis (WOMAC) index and Visual Analogue Scale (VAS) for pain were analyzed at time 0 and at 4 and 12 weeks. Health-related quality of life by ShortForm36, inflammation by C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were also evaluated, together with a body composition assessment performed by DXA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized placebo controlled study. 90 days of treatment with 600 mg/d of non-animal Chondroitin Sulphate or placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: PlaceboPlacebo. For 90 days one capsule/day. |
| Intervention Group | Experimental | Biological: Non-Animal Chondroitin Sulphate600 mg/day of non-animal Chondroitin Sulphate. One capsule/day for 90 days. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caucasian subjects, males and females, with the following characteristics were included in the trial and randomly assigned to the experimental group (N=30) or a control group (N=30): Individuals overweight (BMI > 25 kg/m2), aged 40-74.; Mobility impairment, joint discomfort or established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA).
Key exclusion criteria (1 listed)
- Anyone with evidence of heart disease, kidney or liver disease, or any other disease that might influence the results of the study was excluded.
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 |
|---|---|---|
| Non-Animal Chondroitin SulphateMythocondro® is an ichthyic-like chondroitin sulfate produced by chemical sulfation of a non-sulfated chondroitin backbone obtained by thermo-acid hydrolysis of the capsular polysaccharide naturally produced by an Escherichia coli strain. | Biological | Intervention Group |
| PlaceboPlacebo | Other | Placebo Group |
Primary outcome
Change in Generic Pain (VAS)
Time frame: 0, 30, 90 days
Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain. A VAS reduction is expected only in treatment group.
Change in Knee Pain (WOMAC)
Time frame: 0, 30, 90 days
Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations. A significant decrease in expected in treatment group.
Change in Knee Functionality (TLKS)
Time frame: 0, 30, 90 days
Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability. An increase in expected in treatment group.
3 secondary outcomes
Change in Quality of Life (SF-36)
Time frame: 0, 30, 90 days
Change in Inflammatory Markers circulating levels (CRP, ESR)
Time frame: 0, 30, 90 days
Change in total Fat Mass, Total Free Fat Mass and Visceral adipose tissue (DXA)
Time frame: 0, 30, 90 days
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 6 Nov 2018.
- Individual participant dataSharing planned: No. Data are planned to be available for Gnosis SpA and together with the study pubblication. IPD will be not available for other researchers.
Related trials for Knee Osteoarthritis
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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.
Mariangela Rondanelli, Professor study director
IRCCS Mondino Foundation, Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-Animal Chondroitin Sulphate in people with Knee Osteoarthritis, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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 1 inclusion and 1 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 6 Nov 2018. 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 Italy. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Generic Pain (VAS) (time frame: 0, 30, 90 days). The study lists 3 primary outcomes in all. 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 6 Nov 2018.