Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee
- Conditions
- Osteoarthritis
- Interventions
- Device: Hylan G-F 20 (GZ402662/SAR402662)Drug: Placebo
- Registration Number
- NCT03190369
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief 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.
- Detailed Description
The duration of the study was 29 weeks at maximum. The screening and wash-out period lasted for up to 14 days, depending on the half-life of the medications followed by an 8-day baseline period including the treatment day. Overall, there were up to 21 days between signing informed consent (at screening visit) and the randomization (Day 1). Treatment was administered on Day 1, and follow-up period was 26 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hylan G-F 20 Hylan G-F 20 (GZ402662/SAR402662) Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. Placebo Placebo Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks From Baseline up to Week 26 The WOMAC Numerical Rating Scale (NRS) version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with Osteoarthritis (OA) of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) From Baseline up to Week 26 Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the on-treatment period (time from the injection of IMP up to Week 26 follow-up visit).
Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks From Baseline up to Week 26 PTGA (self-assessment of target knee OA condition) was measured using an 11-point NRS ranging from 0 (best possible) to 10 (worst possible), where lower score represented best possible condition and higher score represented worst possible condition.
Change From Baseline in WOMAC A Score Over 26 Weeks From Baseline up to Week 26 The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A (5 items: measure of pain while walking, using stairs, at night while in bed, sitting or lying, and standing); each item was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. Total WOMAC A score was the sum of 5 item scores and ranges from 0 (none) to 50 (extreme); where lower score represented no pain and higher score represented extreme pain.
Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks From Baseline up to Week 26 COGA was used by the physicians to perform a global assessment of the participant's target knee OA condition. The response was captured using the 11-point NRS pain intensity rating scale ranging from 0 (best possible) to 10 (worst possible) at the specified time points, where lower score represented best possible condition and higher score represented worst possible condition.
Percentage of Positive WOMAC A1 Responder Over 26 Weeks Week 4, Week 8, Week 12, Week 16, Week 20 and Week 26 WOMAC A1 responder were defined as \>=2-point improvement from baseline in the WOMAC A1 NRS. The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain.
Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks From Baseline up to Week 26 The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. For 7-day average WOMAC A1, the baseline value was defined as the average of the WOMAC A1 scores recorded 7 days prior to the first investigational medicinal product (IMP) administration (WOMAC A1 score recorded on Day 1 included). The 7-day average WOMAC A1 was set as missing if 3 or more of the 7 WOMAC A1 scores were missing.
Trial Locations
- Locations (21)
Investigational Site Number 1560013
🇨🇳Changsha, China
Investigational Site Number 1560009
🇨🇳Beijing, China
Investigational Site Number 1560002
🇨🇳Shanghai, China
Investigational Site Number 1560008
🇨🇳Wuxi, China
Investigational Site Number 1560001
🇨🇳Beijing, China
Investigational Site Number 1560005
🇨🇳Beijing, China
Investigational Site Number 1560020
🇨🇳Beijing, China
Investigational Site Number 1560012
🇨🇳Changchun, China
Investigational Site Number 1560023
🇨🇳Chengdu, China
Investigational Site Number 1560016
🇨🇳Guangzhou, China
Investigational Site Number 1560011
🇨🇳Hohhot, China
Investigational Site Number 1560017
🇨🇳Kunming, China
Investigational Site Number 1560007
🇨🇳Qingdao, China
Investigational Site Number 1560003
🇨🇳Shanghai, China
Investigational Site Number 1560022
🇨🇳Shanghai, China
Investigational Site Number 1560018
🇨🇳Taiyuan, China
Investigational Site Number 1560010
🇨🇳Tianjin, China
Investigational Site Number 1560015
🇨🇳Tianjin, China
Investigational Site Number 1560006
🇨🇳Wuhan, China
Investigational Site Number 1560019
🇨🇳Nanjing, China
Investigational Site Number 1560021
🇨🇳Nanjing, China