Knee OsteoarthritisPhase 3MOTIONNCT05632783
TreatMent Of Knee osTeoarthritis wIth chONdroitin Sulfate - the OA MOTION Study
A Phase 3 study testing Chondroitin Sulfate Sodium in people with Knee Osteoarthritis, run by IBSA Institut Biochimique SA.
Trial summary
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Chondroitin Sulfate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jul 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent for participation in the clinical study.
- Subject is outpatient of either sex, aged ≥50 years.
- Subjects with a diagnosis of OA (osteoarthritis) according to the ACR (American College of Rheumatology) criteria.
- Subject has a radiographic diagnosis (confirmed by a central reader) of knee OA classified Kellgren-Lawrence Grade of 2 or 3 on standing anterior-posterior X-ray of the index knee based on an x ray assessment of both knees available <6 months from Screening or performed during Screening.
- Subject has a history of knee OA for >6 months (including regular pain and functional impairment) as confirmed by the investigator, based on available written documentation and/or subject reporting.
- Subject meets the following requirements:
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- Has a mean score of ≥5 to ≤9 on the 24-hour average daily pain score in the index knee (0-10 Numerical Rating Scale-NRS), where the mean is calculated over all values that are available in the 7 days prior to randomization (Day 1), and it is required that at least 5 pain score values will be available during that period.
- Subject has an individual index knee 24-hour average daily pain score ≥1 and ≤9 for all values that are available in the 7 days prior to randomization (Day 1).
- Subject has rated the pain in the non index knee consistently lower than the pain in the index knee at both the Screening and Baseline Visits in case of bilateral knee OA.
- Subject, if of childbearing potential, is nonlactating and nonpregnant (has negative serum pregnancy test results at Screening and negative urine pregnancy test result at the start of IP administration prior to dosing).
- Subject, if female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following medically acceptable methods of birth control:
- Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before IP administration.
- Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the subject's usual lifestyle. Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
- Intrauterine device.
- Double barrier method (condoms, sponge, diaphragm, with spermicidal jellies, or cream).
- Subject able to understand and follow the study requirements.
Who cannot join
- Subject with an allergy or hypersensitivity to the active substance or to any other ingredient of the IP (i.e., chondroitin sulfate tablets or placebo) or has a vegan lifestyle.
- Subject presenting with lactose intolerance.
- Subject with ≥1 pain score reported as 10 on the NRS during the 7 days prior to randomization (Day 1).
- Subject with New York Heart Association Grade III-IV with an ongoing treatment.
- Subject with severe renal or hepatic impairment (Child-Pugh Stage C) with renal and liver function assessment based on laboratory results.
- Subject with any other clinically severe or significant uncontrolled concurrent illness.
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- Subject with any other concurrent illness requiring chronic use of analgesics/NSAIDs (nonsteroidal anti-inflammatory drug).
- Subject has a body mass index ≥40 kg/m2.
- Subject has predominantly patellofemoral osteoarthritis based on clinical diagnosis and/or x-ray.
- Subject had surgery of the index knee in the past 6 months (for arthroscopic surgery) or 12 months (for osteotomy or other surgery) or significant injuries in the past 6 months prior to Screening, or has planned knee surgery during the study.
- Subject with presence of clinical effusion of the knee requiring arthrocentesis or active infection of the index knee.
- Subject has any important genu varum or valgum >8°(physiological angle including) or any other axial disorder justifying an osteotomy as assessed by central reading.
- Subject had viscosupplementation, tidal lavage, platelet-rich plasma, or stem cell injection within the last 6 months before Screening.
- Subject has systemic inflammatory arthropathies (rheumatic disease, inflammatory, infective, or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropathies; osteo-articular pathologies differing from arthrosis; ochronosis; acromegaly; heritable disorders; or collagen gene mutations), metabolic arthropathies, or Paget's illness.
- History of acquired or congenital immunodeficiency diseases or positive test results for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus current infection at Screening.
- Subject has received any of the following:
- Basic treatment of arthritis with food supplements for joint care (chondroitin sulfate, glucosamine sulfates, diacerein, hyaluronic acid etc.) within the last 3 months.
- Treatment with oral or parental corticoids during the last month or corticosteroid joint injection within the last 3 months; treatment with inhaled corticosteroids is allowed.
- Any medication having an influence on pain:
- NSAIDs (washout period begins ≥5 half-lives of the drug prior to Day 7 and needs to be completed prior to Day 7);
- Hypnotics, muscle relaxants, anxiolytics, if intake has started <8 days before Screening to be completed prior to Day -7;
- Use of cannabinoids needs to be stopped ≥2 weeks before the Screening Visit;
- Acetaminophen or other analgesics (washout period begins ≥5 half-lives of the drug prior to Day 7 and needs to be completed prior to Day -7).
- Subject has foreseen physiotherapy or alternative medicine (mesotherapy, acupuncture) within the next 12 months (study period).
- Subject is presenting with clinically relevant psychiatric illness hindering the protocol compliance.
- Subject is presenting with alcoholism or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria, or has a positive drug screen result at the Screening or the Baseline Visit. The use of tricyclic antidepressants at low doses for sleep is allowed.
- Subject has participated in any other clinical study in the month prior to Screening.
- Subject is noncompliant with eDiary use as determined at the Baseline Visit (i.e., has a compliance <70% throughout the entire Screening Period).
- -
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Chondroitin Sulfate 800 mg Tablets Versus Placebo in Subjects With Pain Due to Knee Osteoarthritis and to Evaluate the Durability of the Effect and Safety of the Treatment
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks).
The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo.
The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.
Read the detailed description
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks). Approximately 690 male and female adult subjects with moderate-to-severe pain due to OA of the knee will be randomized in a 1:1 ratio to receive either chondroitin sulfate 800 mg tablets (CS) or matching placebo. Subjects will orally self administer chondroitin sulfate/placebo once daily at home during the double blind treatment period of 36 weeks. The first approximately 250 subjects who reach Week 36 and are willing to further participate in the study will attend a double blind long-term safety follow-up period and will continue to self administer chondroitin sulfate/placebo for 12 additional weeks (up to week48). Acetaminophen 500 mg oral tablets, max. 6 tablets per day (rescue medication), will be the only analgesic allowed for the clinical study to treat pain of any type.
The study will include the following endpoints:
Primary Efficacy (Double-blind Treatment Period until Week 36) • Change from Baseline to Week 24 in the weekly mean of the average daily pain in the index knee as measured by the numerical rating scale (NRS) (0 10 points)
Key Secondary Efficacy (Double-blind Treatment Period until Week 36)
- Change from Baseline to Week 24 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale
- Subject's global evaluation at Week 24 as measured by Patient Global Impression of Change (PGIC)
- Change from Baseline to Week 36 in the weekly mean of the average daily pain in the index knee as measured with the NRS (durability of effect)
Other Secondary Efficacy (Double-blind Treatment Period until Week 36)
- Change from Baseline to each week until Week 36 in the weekly mean of the average daily pain in the index knee as measured with the NRS
- Change from Baseline to Weeks 4, 12, 24, and 36 in WOMAC total score and all WOMAC subscores
- Consumption of rescue medication (acetaminophen), including the number of intake days, number of daily intakes, and total dose per day
- Change from Baseline to Weeks 4, 12, 24, and 36 in subject's quality of life (Short Form 36 Health Survey Questionnaire [SF-36])
- Subject's global evaluation at Weeks 4, 12, and 36 as measured by PGIC
- Investigator's global evaluation at Weeks 4, 12, 24, and 36 by Clinician Global Impression of Change (CGIC)
- Responder rates at each visit using 2 different response definitions (≥30% or ≥50% decrease in weekly mean of the average daily [24 hour] NRS pain intensity score)
Safety and Tolerability (Double-blind Treatment Period until Week 36)
- Number of subjects with any adverse events (AEs), treatment emergent adverse events (TEAEs), AEs causally related to the investigational product (IP) (ADRs), and serious adverse events (SAEs)
- Number of dropouts due to AEs and dropouts due to AEs causally related to the IP (ADRs)
- IP Compliance
- Subject's treatment satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) at Weeks 4, 12, 24, and 36
- Change in laboratory parameters from Baseline to Weeks 4, 12, 24, and 36
- Change in 12 lead electrocardiogram (ECG) parameters from Baseline to Week 24
- Change in vital signs from Baseline to each post-baseline visit
Safety Follow-up Period from Weeks 36 to 48 with Continued Double-blind Treatment for those subjects who continue in the study until Week 48 (planned number: approximately 250 subjects)
Primary Safety
- Number of subjects with any AEs, TEAEs, ADRs, and SAEs
Secondary Safety
- Changes from Baseline to Week 48 in vital signs, ECG, and safety laboratory results
- Changes from Baseline to Week 48 in subject's treatment satisfaction as measured by the MSQ
Exploratory Efficacy
- To explore the long-term efficacy of once daily treatment with CS 800 mg oral tablets
- Change from Baseline to Week 48 in the weekly mean of the average daily pain in the index knee as measured by the NRS (0 10 points)
- Change from Baseline to Week 48 in WOMAC total score and all subscale scores
- Change from Baseline to Week 48 in subject's quality of life (SF-36)
- Subject's global evaluation as measured by PGIC at Week 48
- Investigator's global evaluation as measured by CGIC at Week 48
Subjects will use an eDiary (electronic diary) to record, daily, their average daily pain in the index knee (by a numerical rating scale) and to record the daily administration of the IP and the frequency and dose of rescue medication taken.
To enter the study, subjects must be outpatients ≥50 years of age and have a documented diagnosis of OA in the index knee, based on the American College of Rheumatology (ACR) Criteria for Classification of Idiopathic OA of the knee. Subjects will not be eligible if they have ≥1 pain score reported as 10 on the NRS during the 7 days prior to randomization (Day 1).
For subjects with bilateral knee pain, the more symptomatic knee (i.e., the more painful knee) will be determined by the investigator together with the subject as the index knee during the Screening Visit.
The screening period of the study will include a washout from analgesics and from other drugs taken for pain (i.e nonsteroidal anti-inflammatory drug) that will be followed by a Run-in Period (Day 7 to Day 1) with a total duration of up to 21 days before randomization. Subjects will return to the study site on Day 1 (Baseline), at Weeks 4 (Day 28), 8 (Day 56), 12 (Day 84), 16 (Day 112), 20 (Day 140), 24 (Day 168), and 36 (Day 252) during the double-blind treatment period of 36 weeks to complete the efficacy, safety, and tolerability assessments as applicable. In addition, those approximately 250 subjects who participate in the safety follow up period will return to the site at Week 48 (Day 336). Regular telephone contacts will occur every 2 weeks between scheduled visits during the double-blind treatment and safety follow-up periods to assess the adverse events and to verify treatment compliance.
- Conditions
- Knee Osteoarthritis
- Being tested
- Chondroitin Sulfate Sodium, Placebo
- Keywords
- osteoarthritis, Pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin Sulfate SodiumDrug
Also called chondroitin sulfate 800 mg
Chondroitin sulfate 800 mg tablets
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| chondroitin sulfate 800 mg tablets | Experimental | oral chondroitin sulfate 800 mg tablet Receives: Drug: Chondroitin Sulfate Sodium |
| placebo | Placebo comparator | oral placebo tablets matching the IP tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of once daily treatment-Change in pain (baseline to week-24) in target knee
Change from Baseline to Week 24 in the weekly mean of the average daily pain in the index knee as measured by the numerical rating scale (NRS) (0 10 points where 0 is "no pain" and 10 "the worst pain imaginable")
Measured: Week 24
Safety of the long term treatment-Primary outcome of Safety Follow-up Period from Weeks 36 and 48 with Continued Double-blind Treatment
Number of subjects with any AEs, TEAEs, ADRs, and SAEs in Safety Follow-up Period from Weeks 36 and 48 with Continued Double-blind Treatment
Measured: 48 weeks
Secondary outcomes (4)
Key secondary endpoint of the Double-blind Treatment Period until Week 36. Efficacy of once daily treatment-Change (baseline to week 24) in target knee function
Change from Baseline to Week 24 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale. WOMAC consists of 24 questions and produces 3 subscale scores for pain (5 questions), stiffness (2 questions), and function (17 questions), and a total score that summarizes overall disability. Only the function subscale will be analyzed for this key secondary endpoint. Each question is scored from 0 to 10 using a standardized 11 point NRS. Each subscale score and the total score will be averaged to provide subscale and total scores between 0 and 10.
Measured: Week 24
Key secondary endpoint of the Double-blind Treatment Period until Week 36. Subject's global evaluation
Subject's global evaluation at Week 24 as measured by Patient Global Impression of Change (PGIC). The PGIC is a self-administered instrument that measures change in subjects' overall improvement with treatment on a scale where 1 = "very much improved" and 7 = "very much worse."
Measured: Week 24
Key secondary endpoint of the Double-blind Treatment Period until Week 36. Durability of the effect (up to week 36)
Durability of effect: change from Baseline to Week 36 in the weekly mean of the average daily pain in the index knee as measured with the Numerical Rating Scale (NRS: 0 10 points where 0 is "no pain" and 10 "the worst pain imaginable")
Measured: Week 36
Safety and tolerability-Double-blind Treatment Period until Week 36.
Number of subjects with any AEs, treatment-emergent adverse events (TEAEs), AEs causally related to the investigational product (IP) (adverse drug reactions [ADRs]), and serious adverse events (SAEs)
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Study canceled before starting
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632783
- Sponsor's protocol ID
- 22US-Ct04
- Acronym
- MOTION
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Chondroitin Sulfate 800 mg Tablets Versus Placebo in Subjects With Pain Due to Knee Osteoarthritis and to Evaluate the Durability of the Effect and Safety of the Treatment
- ClinicalTrials.gov ID
- NCT05632783
- Acronym / sponsor ID
- MOTION / 22US-Ct04
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study canceled before starting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Dec 2022 (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.
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks).
The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo.
The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.
Detailed description
The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks). Approximately 690 male and female adult subjects with moderate-to-severe pain due to OA of the knee will be randomized in a 1:1 ratio to receive either chondroitin sulfate 800 mg tablets (CS) or matching placebo. Subjects will orally self administer chondroitin sulfate/placebo once daily at home during the double blind treatment period of 36 weeks. The first approximately 250 subjects who reach Week 36 and are willing to further participate in the study will attend a double blind long-term safety follow-up period and will continue to self administer chondroitin sulfate/placebo for 12 additional weeks (up to week48). Acetaminophen 500 mg oral tablets, max. 6 tablets per day (rescue medication), will be the only analgesic allowed for the clinical study to treat pain of any type.
The study will include the following endpoints:
Primary Efficacy (Double-blind Treatment Period until Week 36) • Change from Baseline to Week 24 in the weekly mean of the average daily pain in the index knee as measured by the numerical rating scale (NRS) (0 10 points)
Key Secondary Efficacy (Double-blind Treatment Period until Week 36)
- Change from Baseline to Week 24 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale
- Subject's global evaluation at Week 24 as measured by Patient Global Impression of Change (PGIC)
- Change from Baseline to Week 36 in the weekly mean of the average daily pain in the index knee as measured with the NRS (durability of effect)
Other Secondary Efficacy (Double-blind Treatment Period until Week 36)
- Change from Baseline to each week until Week 36 in the weekly mean of the average daily pain in the index knee as measured with the NRS
- Change from Baseline to Weeks 4, 12, 24, and 36 in WOMAC total score and all WOMAC subscores
- Consumption of rescue medication (acetaminophen), including the number of intake days, number of daily intakes, and total dose per day
- Change from Baseline to Weeks 4, 12, 24, and 36 in subject's quality of life (Short Form 36 Health Survey Questionnaire [SF-36])
- Subject's global evaluation at Weeks 4, 12, and 36 as measured by PGIC
- Investigator's global evaluation at Weeks 4, 12, 24, and 36 by Clinician Global Impression of Change (CGIC)
- Responder rates at each visit using 2 different response definitions (≥30% or ≥50% decrease in weekly mean of the average daily [24 hour] NRS pain intensity score)
Safety and Tolerability (Double-blind Treatment Period until Week 36)
- Number of subjects with any adverse events (AEs), treatment emergent adverse events (TEAEs), AEs causally related to the investigational product (IP) (ADRs), and serious adverse events (SAEs)
- Number of dropouts due to AEs and dropouts due to AEs causally related to the IP (ADRs)
- IP Compliance
- Subject's treatment satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) at Weeks 4, 12, 24, and 36
- Change in laboratory parameters from Baseline to Weeks 4, 12, 24, and 36
- Change in 12 lead electrocardiogram (ECG) parameters from Baseline to Week 24
- Change in vital signs from Baseline to each post-baseline visit
Safety Follow-up Period from Weeks 36 to 48 with Continued Double-blind Treatment for those subjects who continue in the study until Week 48 (planned number: approximately 250 subjects)
Primary Safety
- Number of subjects with any AEs, TEAEs, ADRs, and SAEs
Secondary Safety
- Changes from Baseline to Week 48 in vital signs, ECG, and safety laboratory results
- Changes from Baseline to Week 48 in subject's treatment satisfaction as measured by the MSQ
Exploratory Efficacy
- To explore the long-term efficacy of once daily treatment with CS 800 mg oral tablets
- Change from Baseline to Week 48 in the weekly mean of the average daily pain in the index knee as measured by the NRS (0 10 points)
- Change from Baseline to Week 48 in WOMAC total score and all subscale scores
- Change from Baseline to Week 48 in subject's quality of life (SF-36)
- Subject's global evaluation as measured by PGIC at Week 48
- Investigator's global evaluation as measured by CGIC at Week 48
Subjects will use an eDiary (electronic diary) to record, daily, their average daily pain in the index knee (by a numerical rating scale) and to record the daily administration of the IP and the frequency and dose of rescue medication taken.
To enter the study, subjects must be outpatients ≥50 years of age and have a documented diagnosis of OA in the index knee, based on the American College of Rheumatology (ACR) Criteria for Classification of Idiopathic OA of the knee. Subjects will not be eligible if they have ≥1 pain score reported as 10 on the NRS during the 7 days prior to randomization (Day 1).
For subjects with bilateral knee pain, the more symptomatic knee (i.e., the more painful knee) will be determined by the investigator together with the subject as the index knee during the Screening Visit.
The screening period of the study will include a washout from analgesics and from other drugs taken for pain (i.e nonsteroidal anti-inflammatory drug) that will be followed by a Run-in Period (Day 7 to Day 1) with a total duration of up to 21 days before randomization. Subjects will return to the study site on Day 1 (Baseline), at Weeks 4 (Day 28), 8 (Day 56), 12 (Day 84), 16 (Day 112), 20 (Day 140), 24 (Day 168), and 36 (Day 252) during the double-blind treatment period of 36 weeks to complete the efficacy, safety, and tolerability assessments as applicable. In addition, those approximately 250 subjects who participate in the safety follow up period will return to the site at Week 48 (Day 336). Regular telephone contacts will occur every 2 weeks between scheduled visits during the double-blind treatment and safety follow-up periods to assess the adverse events and to verify treatment compliance.
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
- Multicenter, Randomized, Double-blind
| Arm | Type | Receives |
|---|---|---|
| chondroitin sulfate 800 mg tablets | Experimental | Drug: Chondroitin Sulfate Sodiumoral chondroitin sulfate 800 mg tablet |
| placebo | Placebo comparator | Other: Placebooral placebo tablets matching the IP tablets |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject has provided written informed consent for participation in the clinical study.
- Subject is outpatient of either sex, aged ≥50 years.
- Subjects with a diagnosis of OA (osteoarthritis) according to the ACR (American College of Rheumatology) criteria.
- Subject has a radiographic diagnosis (confirmed by a central reader) of knee OA classified Kellgren-Lawrence Grade of 2 or 3 on standing anterior-posterior X-ray of the index knee based on an x ray assessment of both knees available <6 months from Screening or performed during Screening.
- Subject has a history of knee OA for >6 months (including regular pain and functional impairment) as confirmed by the investigator, based on available written documentation and/or subject reporting.
Key exclusion criteria (29 listed)
- Subject with an allergy or hypersensitivity to the active substance or to any other ingredient of the IP (i.e., chondroitin sulfate tablets or placebo) or has a vegan lifestyle.
- Subject presenting with lactose intolerance.
- Subject with ≥1 pain score reported as 10 on the NRS during the 7 days prior to randomization (Day 1).
- Subject with New York Heart Association Grade III-IV with an ongoing treatment.
- Subject with severe renal or hepatic impairment (Child-Pugh Stage C) with renal and liver function assessment based on laboratory results.
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 |
|---|---|---|
| Chondroitin Sulfate SodiumAlso: chondroitin sulfate 800 mgChondroitin sulfate 800 mg tablets | Drug | chondroitin sulfate 800 mg tablets |
| PlaceboPlacebo tablets | Other | placebo |
Primary outcome
Efficacy of once daily treatment-Change in pain (baseline to week-24) in target knee
Time frame: Week 24
Change from Baseline to Week 24 in the weekly mean of the average daily pain in the index knee as measured by the numerical rating scale (NRS) (0 10 points where 0 is "no pain" and 10 "the worst pain imaginable")
Safety of the long term treatment-Primary outcome of Safety Follow-up Period from Weeks 36 and 48 with Continued Double-blind Treatment
Time frame: 48 weeks
Number of subjects with any AEs, TEAEs, ADRs, and SAEs in Safety Follow-up Period from Weeks 36 and 48 with Continued Double-blind Treatment
4 secondary outcomes
Key secondary endpoint of the Double-blind Treatment Period until Week 36. Efficacy of once daily treatment-Change (baseline to week 24) in target knee function
Time frame: Week 24
Key secondary endpoint of the Double-blind Treatment Period until Week 36. Subject's global evaluation
Time frame: Week 24
Key secondary endpoint of the Double-blind Treatment Period until Week 36. Durability of the effect (up to week 36)
Time frame: Week 36
Safety and tolerability-Double-blind Treatment Period until Week 36.
Time frame: week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chondroitin Sulfate Sodium in people with Knee Osteoarthritis, run by IBSA Institut Biochimique SA.
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 16 inclusion and 29 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: withdrawn, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of once daily treatment-Change in pain (baseline to week-24) in target knee (time frame: Week 24). The study lists 2 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 5 Oct 2023.