NCT03190369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

June 14, 2017

Results QC Date

January 19, 2020

Last Update Submit

March 15, 2022

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks

    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.

    From Baseline up to Week 26

Secondary Outcomes (6)

  • Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks

    From Baseline up to Week 26

  • Change From Baseline in WOMAC A Score Over 26 Weeks

    From Baseline up to Week 26

  • Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks

    From Baseline up to Week 26

  • Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks

    From Baseline up to Week 26

  • Percentage of Positive WOMAC A1 Responder Over 26 Weeks

    Week 4, Week 8, Week 12, Week 16, Week 20 and Week 26

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.

Drug: Placebo

Hylan G-F 20

EXPERIMENTAL

Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks.

Device: Hylan G-F 20 (GZ402662/SAR402662)

Interventions

Hylan G-F 20 (GZ402662/SAR402662)DEVICE

Pharmaceutical form: Solution for injection Route of administration: Intra articular

Also known as: Synvisc-One
Hylan G-F 20
PlaceboDRUG

Pharmaceutical form: Solution for injection Route of administration: Intra articular

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic OA of the target knee joint with WOMAC A1 NRS score of \>=4.0 and less than or equal to (\<=) 8.0 as recorded in the baseline period.
  • Confirmed by standard X-rays performed within 3 months prior to screening visit: modified Kellgren-Lawrence Numerical Grading System of Grade I-III in the target knee joint.
  • According to the American College of Rheumatology (ACR) Criteria.
  • With failure to respond adequately to conservative non-pharmacologic therapy and/or simple analgesics, such as acetaminophen.
  • Participant was willing and was able to provide signed informed consent prior to any study related procedures being performed.

You may not qualify if:

  • The score of contralateral knee pain (if present) \>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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Investigational Site Number 1560001

Beijing, 100044, China

Location

Investigational Site Number 1560005

Beijing, 100050, China

Location

Investigational Site Number 1560020

Beijing, 100191, China

Location

Investigational Site Number 1560009

Beijing, 100730, China

Location

Investigational Site Number 1560012

Changchun, 130021, China

Location

Investigational Site Number 1560013

Changsha, 410008, China

Location

Investigational Site Number 1560023

Chengdu, 610041, China

Location

Investigational Site Number 1560016

Guangzhou, 510080, China

Location

Investigational Site Number 1560011

Hohhot, 010017, China

Location

Investigational Site Number 1560017

Kunming, 650032, China

Location

Investigational Site Number 1560019

Nanjing, 210009, China

Location

Investigational Site Number 1560021

Nanjing, 210029, China

Location

Investigational Site Number 1560007

Qingdao, 266003, China

Location

Investigational Site Number 1560002

Shanghai, 200011, China

Location

Investigational Site Number 1560003

Shanghai, 200032, China

Location

Investigational Site Number 1560022

Shanghai, 200072, China

Location

Investigational Site Number 1560018

Taiyuan, 030001, China

Location

Investigational Site Number 1560010

Tianjin, 300052, China

Location

Investigational Site Number 1560015

Tianjin, 300192, China

Location

Investigational Site Number 1560006

Wuhan, 430033, China

Location

Investigational Site Number 1560008

Wuxi, 214023, China

Location

Related Publications (1)

  • Ke Y, Jiang W, Xu Y, Chen Y, Zhang Q, Xue Q, Lin J, Ngai W, Nian G, Fazeli MS, Xie Y, Zhu Z. 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. BMC Musculoskelet Disord. 2021 May 8;22(1):428. doi: 10.1186/s12891-021-04252-2.

    PMID: 33964907DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi aventis recherche & développement
Contact-US@sanofi.com
800-633-1610

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

August 21, 2017

Primary Completion

January 28, 2019

Study Completion

January 28, 2019

Last Updated

March 25, 2022

Results First Posted

February 5, 2020

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

CN(21)