A Phase 3 interventional study of SP5M002 inj and Synovian inj in Osteoarthritis, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Active, not recruiting at 16 sites in Korea, Republic of. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 3, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 297 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Compared within Osteoarthritis, Knee, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Having the following diseases that may affect the efficacy and safety evaluation but not being limited to the following
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
The following clinically significant diseases in the past or present
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SP5M002 inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients
Device: SP5M002 inj
Synovian inj 3 ml pre-filled syringe into Knee joint cavity of osteoarthritis patients
Device: Synovian inj
pre-filled syringe
pre-filled syringe
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)
Time frame: 12 weeks
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)
Time frame: 6 weeks
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)
Time frame: week 2, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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)
Time frame: week 2,6,12, 24, 36
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.
Time frame: week 2,6,12, 24, 36
Proportion (%) of participants who took rescue medication at each post-administration visit and dose of rescue medication (Weeks 2, 6, 12, 24, and 36)
Time frame: week 2,6,12, 24, 36
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
Time frame: week 2,6,12, 24, 36
The incidence rate of Pre-treatment AEs
Time frame: From Week 0 to week 24
The incidence rate of Solicited Local AEs
Time frame: From Week 0 to week 24
The incidence rate of treatment-emergent adverse event (TEAE)
Time frame: From Week 0 to week 24
The incidence rate of Serious TEAEs
Time frame: From Week 0 to week 24
The incidence rate of Serious TEAEs leading to Drug withdrawn
Time frame: From Week 0 to week 24
The incidence rate of Serious TEAEs leading to Death
Time frame: From Week 0 to week 24
The incidence rate of abnormal CS at Post-Treatment on Laboratory
Time frame: From Week 0 to week 24
The incidence rate of abnormal CS at Post-Treatment on Electrocardiogram
Time frame: From Week 0 to week 24
The incidence rate of abnormal on Physical Examination
Time frame: From Week 0 to week 24
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Shin Poong Pharmaceutical Co. Ltd. →