Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06399042
Other study ID # SP-HA-003-1
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 14, 2023
Est. completion date September 2024

Study information

Verified date April 2024
Source Shin Poong Pharmaceutical Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 297
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: 1. Adult males and females aged 40 years or older as of the date of written consent 2. Subject with knee osteoarthritis whose X-ray test results within 6 months from the screening or at the screening visit correspond to grades I - III of the Kellgren & Lawrence scale 3. Subject diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical diagnostic criteria of the American College of Rheumatology (ACR) at screening who have knee joint pain and meet three or more of the following conditions - Over 50 years of age - Less than 30 minutes of morning stiffness ? Crepitus on active motion ? Bony tenderness ? Bony enlargement ? No palpable warmth of synovium 4. Weight bearing pain (WBP) of at least one of both knee joints on 100 mm-VAS = 40 mm when measured at screening and baseline [However, if both sides have symptoms, the knee joint with the higher WBP becomes the joint for evaluation, and the selected joint cannot be changed during the study period.] 5. Walk without relying on a walking aid such as a walker or cane (patients who have been using a walking aid every day since 6 months prior to the screening visit can use the walking aid, and must use the walking aid in the same way throughout the study period.) 6. Ability to fully understand and complete the safety and efficacy measurement questionnaire 7. Voluntary decision for participation and provision of written consent to comply with the precautions after hearing and fully understanding the detailed explanation of the purpose, method, and effects of this study Exclusion Criteria: 1. Body mass index (BMI) = 35 kg/m2 at screening 2. Hip osteoarthritis or osteoarthritis of another joint that is severe enough to preclude evaluation of knee osteoarthritis at the time of screening 3. Having the following diseases that may affect the efficacy and safety evaluation but not being limited to the following - Septic arthritis, rheumatoid arthritis, gout, recurrent pseudogout arthritis, trauma that may damage joint cartilage, congenital abnormalities, calcium deposition disease, diabetes, ochronosis, hemochromatosis, acromegaly, Wilson's disease, primary osteochondrosis, genetic diseases (e.g., hyperkinesis), secondary osteoarthritis caused by collagen gene abnormalities, etc. - Sudek's atrophy or severe painful diseases such as Paget's disease 4. Infection or skin disease in the joint area that is unsuitable for injection at the time of screening 5. Active or suspected knee joint infection at the time of screening 6. Complete loss of the Patello-femoral joint space 7. Received the following treatments within 14 days of the screening visit (except those who have passed a 14-day wash-out) or scheduled to be administered during the study period - Taking medicines containing ingredients such as glucosamine, chondroitin sulfate, and diacerhein - Taking herbal medicines and herbal medicines for osteoarthritis - Taking anti-inflammatory painkillers, non-steroidal anti-inflammatory drugs (NSAIDs, prescription/non-prescription drugs), etc. (administration of acetaminophen allowed if passing a 3 day wash-out) - Taking oral steroids - Hospital physical therapy or oriental medicine treatment (cupping, acupuncture, moxibustion, etc.) 8. Intra-articular injection, such as intra-articular corticosteroid, at the injection site within 6 months from the time of screening 9. Systemic use of steroids within 3 months from the time of screening (including inhalants, however, topical application is permitted only on the upper body) 10. Surgical operations such as knee joint replacement, including arthroscopic surgery, at the administration site within 6 months from the time of screening; or expecting surgery within 6 months 11. Moderate or severe joint effusion by Patella tap test at the screening visit 12. History of hypersensitivity to ingredients of the IP or active control drug 13. Antiplatelet agents (excluding aspirin of 300 mg/day or less), heparin, oral anticoagulants (coumarin anticoagulants, thrombin inhibitors, Factor Xa inhibitors, etc.), and thrombolytics must be used during the study 14. Clinically significant abnormalities in liver function (3 times or more than the upper limit of normal for ALT/AST) or abnormalities in renal function (3 times or more than the upper limit of normal for serum creatinine), or severe liver or renal disease at the discretion of the investigator which is judged to have an impact on the effectiveness and safety evaluation of the study 15. The following clinically significant diseases in the past or present - Diagnosis of malignancy within 5 years prior to screening or currently - Cardiac disorders (myocardial infarction, coronary artery bypass surgery, arrhythmia, and other serious Cardiac disorders, etc.) - Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg) - Severe endocrine diseases (diabetes insipidus, Cushing's disease, etc.) which is judged to have an impact on the efficacy and safety evaluation of the study 16. Currently pregnant or lactating; or planning to become pregnant/lactating during this study 17. Women of childbearing age who have not undergone sterilization surgery, women less than 1 year after menopause, or men who do not agree to avoid pregnancy or use appropriate contraceptive methods during the study period 18. Planned to participate in another study during the study period or having administered (applied) other investigational product (investigational device) within 3 months prior to the screening visit 19. Difficult to conduct the study as judged by the investigator due to other reasons

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SP5M002 inj
pre-filled syringe
Synovian inj
pre-filled syringe

Locations

Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chonnam National University Bitgoeul Hospital Gwangju
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Jeonbuk National University Hospital Jeonju
Korea, Republic of Gyeongsang National University Hospital Jinju
Korea, Republic of Chungnam National University Hospital Sejong
Korea, Republic of CHA University Bundang Medical Center Seongnam
Korea, Republic of EWHA Womans University Mokdong Hospital Seoul
Korea, Republic of Gangnam Severance Hospita Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of Kyunghee University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other The incidence rate of Pre-treatment AEs From Week 0 to week 24
Other The incidence rate of Solicited Local AEs From Week 0 to week 24
Other The incidence rate of treatment-emergent adverse event (TEAE) From Week 0 to week 24
Other The incidence rate of Serious TEAEs From Week 0 to week 24
Other The incidence rate of Serious TEAEs leading to Drug withdrawn From Week 0 to week 24
Other The incidence rate of Serious TEAEs leading to Death From Week 0 to week 24
Other The incidence rate of abnormal CS at Post-Treatment on Laboratory From Week 0 to week 24
Other The incidence rate of abnormal CS at Post-Treatment on Electrocardiogram From Week 0 to week 24
Other The incidence rate of abnormal on Physical Examination From Week 0 to week 24
Primary Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2) * Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS) 12 weeks
Primary Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 6 from baseline (visit 2) * Weight Bearing Pain (WBP) - 100mm-visual analogue scale (VAS) 6 weeks
Secondary Changes in the following at each visit: Weight Bearing pain (WBP) (Weeks 2, 24, and 36) from baseline (Visit 2) Outcome Measurement of Weight Bearing pain(WBP): 100mm-visual analogue scale (VAS) week 2, 24, 36
Secondary Changes in the following at each visit: Rest pain (RP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) Outcome Measurement of Rest pain (RP): 100mm-visual analogue scale (VAS) week 2,6,12, 24, 36
Secondary Changes in the following at each visit: Night pain (NP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) Outcome Measurement of Night pain (NP): 100mm-visual analogue scale (VAS) week 2,6,12, 24, 36
Secondary Changes in the following at each visit: Motion pain (MP) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) Outcome Measurement of Motion pain (MP): 100mm-visual analogue scale (VAS) week 2,6,12, 24, 36
Secondary Changes in the following at each visit: Patient Global Assessment(PGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) Outcome Measurement of Patient Global Assessment(PGA): 100mm-visual analogue scale (VAS) week 2,6,12, 24, 36
Secondary Changes in the following at each visit: Investigator Global Assessment (IGA) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) Outcome Measurement of Investigator Global Assessment (IGA) : 100mm-visual analogue scale (VAS) week 2,6,12, 24, 36
Secondary Changes in the following at each visit: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and individual score evaluation (Pain, function, stiffness) (Weeks 2, 6, 12, 24, and 36) from baseline (Visit 2) Outcome Measurement of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and individual score evaluation (Pain, function, stiffness) : WOMAC-Likert Assessment (5-point Likert scale) week 2,6,12, 24, 36
Secondary Physical assessments at each post-administration visit: Swelling (Weeks 2, 6, 12, 24, and 36) Outcome Measurement of Swelling : 4-point scale
*4-point scale: 0(none)/1(mild)/2(moderate)/3(severe)
week 2,6,12, 24, 36
Secondary Physical assessments at each post-administration visit: joint-line tenderness on pressure (Weeks 2, 6, 12, 24, and 36) Outcome Measurement of joint-line tenderness on pressure : 4-point scale
*4-point scale: 0(none)/1(mild)/2(moderate)/3(severe)
week 2,6,12, 24, 36
Secondary Physical assessments at each post-administration visit: range of motion (Weeks 2, 6, 12, 24, and 36) The angle was recorded as is for the range of motion. week 2,6,12, 24, 36
Secondary Proportion (%) of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36) week 2,6,12, 24, 36
Secondary Post-administration response rate A. Proportion at which WBP decreases by at least 20 mm or improves by at least 40% from baseline at the time of evaluation (B section-Description) *B. Response rate of OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) I. At least 50% improvement in WOMAC pain or function at the time of evaluation; or at least a 20 point improvement from baseline; or II. meeting 2 of the 3 conditions below
At least 20% improvement in WOMAC pain, at least a 10 point improvement from each baseline At least 20% improvement in WOMAC function, at least a 10 point improvement from each baseline At least 20% improvement in patient's global assessment (100 mm-VAS) and at least a 10 point improvement from each baseline
week 2,6,12, 24, 36
See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A