Phase 3
Completed N=440
Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT03190369 ↗Enrolled (actual)
440
Serious AEs
5.5%
Results posted
Feb 2020
Primary outcomePrimary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks — -2.271; -2.146 score on a scale — p=0.3610
◆ Published Evidence
Emerging
14citations · ~3 / year
Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis : C-SOUND study, a 26-week multicenter double-blind randomized placebo-controlled trial in China.
Summary
Primary Objective:
-To evaluate the efficacy of a single 6-milliliter (mL) intra-articular (IA) injection of Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numerical Rating Scale (NRS) 3.1 A1 score, in comparison to an IA placebo injection over 26 weeks, in Chinese participants with symptomatic Osteoarthritis (OA) of the knee.
Secondary Objectives:
* To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 7-day average score of WOMAC A1 pain sub-score in comparison to an IA placebo injection over 26 weeks.
* To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by WOMAC A, patient global assessment (PTGA) and clinical observer global assessment (COGA) in comparison to an IA placebo injection over 26 weeks.
* To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in comparison to an IA placebo injection over 26 weeks. Response was defined as WOMAC A1 greater than or equal to (>=) 2-point improvement from baseline on NRS.
* To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to an IA placebo injection over 26 weeks.
Linked Publications
-
Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis : C-SOUND study, a 26-week multicenter double-blind randomized placebo-controlled trial in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks |
-2.271; -2.146 | 0.3610 |
| SECONDARY Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks |
-2.275; -2.176 | — |
| SECONDARY Change From Baseline in WOMAC A Score Over 26 Weeks |
-8.747; -8.621 | — |
| SECONDARY Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks |
-2.138; -2.144 | — |
| SECONDARY Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks |
-2.145; -2.225 | — |
| SECONDARY Percentage of Positive WOMAC A1 Responder Over 26 Weeks |
58.6; 53.2; 65.0; 62.4; 66.4; 62.8 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
142; 134 | — |
Eligibility Criteria
Inclusion criteria
- Symptomatic OA of the target knee joint with WOMAC A1 NRS score of >=4.0 and less than or equal to ( 3.0 NRS at screening visit.
- Ipsilateral hip OA.
- Participant with systemic corticosteroids within 12 weeks prior to screening visit.
- Participant with injection of IA corticosteroids in the target knee joint within 26 weeks prior to screening visit.
- Concurrent chronic pain conditions with pain score >3.0 NRS at screening, or peripheral or central neuropathy that may affect sensation of the target knee area, including but not limited to back pain, hip pain, disc herniation, sciatica, diabetic neuropathy, post-stroke pain or fibromyalgia.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03190369) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.