Osteoarthritis, KneePhase 4PIONEERNCT05214807
Long-term Safety and Performance of KiOmedine CM-Chitosan Supplementation in Advanced Symptomatic Knee Osteoarthritis
A Phase 4 study testing KiOmedine® CM-Chitosan and Synvisc-One® in people with Osteoarthritis, Knee, run by Kiomed Pharma at 1 site in Belgium.
Trial summary
A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD. In the study, 92 patients meeting eligibility criteria will be randomly assigned to two groups respectively of 46 subjects receiving a single injection of the IMD and 46… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- KiOmedine® CM-Chitosan and Synvisc-One®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jan 2022to 20 Feb 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 40 years and ≤ 85 years.
- Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, a BMI ≥ 30 kg/m2, and/or a Kellgren and Lawrence grade III or IV classification:
- Patellofemoral osteoarthritis referring to symptoms, including pain, that are principally of patellofemoral origin (Patellar syndrome).
- Radiological Kellgren and Lawrence grade III to IV from a standing knee radiograph taken less than 6 months previously.
- Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology (ACR).
- Single intra-articular corticosteroid injection during the screening visit (V0), according to standard clinical practice, to resolve clinically apparent knee effusion and/or local signs of inflammation. Patients can only participate in the clinical investigation when there is no sign of effusion and no local signs of inflammation at the patient in visit (V1) which is planned 1-2 weeks after the screening visit.
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- Moderate to severe symptomatic pain (i.e., total score on the WOMAC pain subscale ≥12) at screening visit in the treatment knee not or poorly responding to first line non-opioid analgesics and non-steroidal anti-inflammatory drug in oral uptake.
- Pain criteria assessed prior to injection using the 5-point Likert WOMAC pain score:
- Treatment knee: moderate to severe pain in the most affected knee (i.e., total score on the WOMAC pain subscale ≥12).
- Non-treatment knee: no to mild pain in the less/non affected knee (i.e., total score on the WOMAC pain subscale ≤5).
- Fully ambulatory patient for functional evaluation.
- For female NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least one year, must have an effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device).
- Able to understand and follow the instructions of the study.
- Having signed a written informed consent.
Who cannot join
- Meeting one of the following contraindications as stated in the instructions for use of KiOmedine® CM-Chitosan or Synvisc® One:
- A known allergy or hypersensitivity to any of the product components,
- Infections or skin disease at or around the injection site,
- Severe inflammation, synovitis or inflammatory arthritis of the knee joint,
- A history of autoimmune and crystal diseases,
- Evidence of lymphatic or venous stasis or serious blood disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Performance of an Intra-articular Injection of KiOmedine CM-Chitosan in Patients With Advanced Symptomatic Knee Osteoarthritis: Single-blind Randomized Controlled Trial With a 12-month Follow-up Period.
A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD. In the study, 92 patients meeting eligibility criteria will be randomly assigned to two groups respectively of 46 subjects receiving a single injection of the IMD and 46 subjects receiving a single injection of Synvisc-One® (Hylan G-F 20) which is selected as comparator. Each patient will be blinded for the treatment he/she receives at the injection visit (single blinding).
The patients will be followed for 12 months post-injection to understand long-term safety and performance effects.
Read more
The study aims to evaluate the safety and performance of a single injection of KiOmedine® CM-Chitosan compared to the comparator device (Synvisc-One®) in patients with advanced symptomatic knee osteoarthritis.
The non-inferiority hypothesis for the primary performance objective is that the percentage mean reduction in pain from baseline at 6 months in the KiOmedine® CM-Chitosan group is non-inferior to that of the comparator group considering a non-inferiority margin. If the hypothesis of non-inferiority is met, then superiority testing will be performed.
- Conditions
- Osteoarthritis, Knee
- Being tested
- KiOmedine® CM-Chitosan, Synvisc-One®
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KiOmedine® CM-ChitosanDevice
KiOmedine® CM-Chitosan is a fluid implant intended for synovial fluid supplementation for the symptomatic treatment of osteoarthritis (OA). This Investigational Medical Device (IMD) is administered via intra-articular injection and is classified as a Class III Device under Council Directive 93/42/EEC (Annex IX, rule 8). A key component of the IMD is a soluble derivative of highly purified chitosan of non-animal origin, an exclusive natural linear glucosamine polysaccharide extracted from the edible white mushroom, Agaricus bisporus. KiOmedine® CM-Chitosan is sterile, non-pyrogenic, resorbable and composed of 2% (w:w) carboxymethyl chitosan (CM-chitosan).
Synvisc-One®Device
Synvisc-One (Hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing Hylan A and Hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of approximately 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains Hylan A and Hylan B (8.0 mg ± 2.0 mg per ml) in buffered physiological sodium chloride solution (pH 7.2 ± 0.3) and is unique in that the hyaluronan is chemically crosslinked.
| Study group | Role | What they receive |
|---|---|---|
| Control group receiving Synvisc-One® | Active comparator | Not described Receives: Device: Synvisc-One® |
| IMD group receiving KiOmedine® CM-Chitosan | Experimental | Not described Receives: Device: KiOmedine® CM-Chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in knee pain at 6 months post-injection measured by the 5-point Likert WOMAC pain scale.
Measured: 6 months
Secondary outcomes (7)
Percentage change from baseline in knee pain measured by the 5-point Likert WOMAC pain scale.
Measured: 2 weeks, 3 months, 9 months and 12 months post-injection.
Percentage change from baseline in knee stiffness measured by the 5-point Likert WOMAC stiffness scale.
Measured: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in physical functioning measured by the 5-point Likert WOMAC physical functioning scale.
Measured: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in the total WOMAC score.
Measured: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in patient's pain and global assessment using an 11-point numerical rating scale.
Measured: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Response to treatment according to the Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT).
Measured: 2 weeks, 3 months, 6 months, 9 months and 12 months post-injection.
Treatment responders with >40% improvement from baseline in pain measured by the 5-point Likert WOMAC pain scale.
Measured: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start26 Jan 2022
- Primary completion20 Aug 2023 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiomed Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathias Schifflers, MD, Study director, Kiomed Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214807
- Sponsor's protocol ID
- KIO014-PIONEER
- Acronym
- PIONEER
- Status last verified
- Mar 2023
- First submitted
- 17 Jan 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of an Intra-articular Injection of KiOmedine CM-Chitosan in Patients With Advanced Symptomatic Knee Osteoarthritis: Single-blind Randomized Controlled Trial With a 12-month Follow-up Period.
- ClinicalTrials.gov ID
- NCT05214807
- Acronym / sponsor ID
- PIONEER / KIO014-PIONEER
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kiomed PharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 31 Jan 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.
A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD. In the study, 92 patients meeting eligibility criteria will be randomly assigned to two groups respectively of 46 subjects receiving a single injection of the IMD and 46 subjects receiving a single injection of Synvisc-One® (Hylan G-F 20) which is selected as comparator. Each patient will be blinded for the treatment he/she receives at the injection visit (single blinding).
The patients will be followed for 12 months post-injection to understand long-term safety and performance effects.
The study aims to evaluate the safety and performance of a single injection of KiOmedine® CM-Chitosan compared to the comparator device (Synvisc-One®) in patients with advanced symptomatic knee osteoarthritis.
The non-inferiority hypothesis for the primary performance objective is that the percentage mean reduction in pain from baseline at 6 months in the KiOmedine® CM-Chitosan group is non-inferior to that of the comparator group considering a non-inferiority margin. If the hypothesis of non-inferiority is met, then superiority testing will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group receiving Synvisc-One® | Active comparator | Device: Synvisc-One® |
| IMD group receiving KiOmedine® CM-Chitosan | Experimental | Device: KiOmedine® CM-Chitosan |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged ≥ 40 years and ≤ 85 years.
- Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, a BMI ≥ 30 kg/m2, and/or a Kellgren and Lawrence grade III or IV classification:
- Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology (ACR).
- Single intra-articular corticosteroid injection during the screening visit (V0), according to standard clinical practice, to resolve clinically apparent knee effusion and/or local signs of inflammation. Patients can only participate in the clinical investigation when there is no sign of effusion and no local signs of inflammation at the patient in visit (V1) which is planned 1-2 weeks after the screening visit.
- Moderate to severe symptomatic pain (i.e., total score on the WOMAC pain subscale ≥12) at screening visit in the treatment knee not or poorly responding to first line non-opioid analgesics and non-steroidal anti-inflammatory drug in oral uptake.
Key exclusion criteria (6 listed)
- Meeting one of the following contraindications as stated in the instructions for use of KiOmedine® CM-Chitosan or Synvisc® One:
- A known allergy or hypersensitivity to any of the product components,
- Infections or skin disease at or around the injection site,
- Severe inflammation, synovitis or inflammatory arthritis of the knee joint,
- A history of autoimmune and crystal diseases,
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 |
|---|---|---|
| KiOmedine® CM-ChitosanKiOmedine® CM-Chitosan is a fluid implant intended for synovial fluid supplementation for the symptomatic treatment of osteoarthritis (OA). This Investigational Medical Device (IMD) is administered via intra-articular injection and is classified as a Class III Device under Council Directive 93/42/EEC (Annex IX, rule 8). A key component of the IMD is a soluble derivative of highly purified chitosan of non-animal origin, an exclusive natural linear glucosamine polysaccharide extracted from the edible white mushroom, Agaricus bisporus. KiOmedine® CM-Chitosan is sterile, non-pyrogenic, resorbable and composed of 2% (w:w) carboxymethyl chitosan (CM-chitosan). | Device | IMD group receiving KiOmedine® CM-Chitosan |
| Synvisc-One®Synvisc-One (Hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing Hylan A and Hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of approximately 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains Hylan A and Hylan B (8.0 mg ± 2.0 mg per ml) in buffered physiological sodium chloride solution (pH 7.2 ± 0.3) and is unique in that the hyaluronan is chemically crosslinked. | Device | Control group receiving Synvisc-One® |
Primary outcome
Percentage change from baseline in knee pain at 6 months post-injection measured by the 5-point Likert WOMAC pain scale.
Time frame: 6 months
7 secondary outcomes
Percentage change from baseline in knee pain measured by the 5-point Likert WOMAC pain scale.
Time frame: 2 weeks, 3 months, 9 months and 12 months post-injection.
Percentage change from baseline in knee stiffness measured by the 5-point Likert WOMAC stiffness scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in physical functioning measured by the 5-point Likert WOMAC physical functioning scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in the total WOMAC score.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Percentage change from baseline in patient's pain and global assessment using an 11-point numerical rating scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Response to treatment according to the Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT).
Time frame: 2 weeks, 3 months, 6 months, 9 months and 12 months post-injection.
Treatment responders with >40% improvement from baseline in pain measured by the 5-point Likert WOMAC pain scale.
Time frame: 2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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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.
Mathias Schifflers, MD study director
Kiomed Pharma
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 KiOmedine® CM-Chitosan and Synvisc-One® in people with Osteoarthritis, Knee, run by Kiomed Pharma at 1 site in Belgium.
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 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. 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 Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
Results are not available in the source record.
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?
Percentage change from baseline in knee pain at 6 months post-injection measured by the 5-point Likert WOMAC pain scale. (time frame: 6 months). 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 8 Mar 2023.