Trial record 1 of 1 for:
EFC12723
Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee (C-SOUND)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03190369 |
Recruitment Status :
Completed
First Posted : June 16, 2017
Results First Posted : February 5, 2020
Last Update Posted : March 25, 2022
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Osteoarthritis |
Interventions |
Device: Hylan G-F 20 (GZ402662/SAR402662) Drug: Placebo |
Enrollment | 440 |
Participant Flow
Recruitment Details | The study was conducted at 21 sites in China from 21 August 2017 to 28 January 2019. A total of 524 participants were screened, of which, 84 participants were screen failures. Screen failures were mainly due to inclusion criteria not met. |
Pre-assignment Details | A total of 440 participants were enrolled and randomized in the study. Assignment to arms was done centrally using an interactive voice response system/interactive web response system (IVRS/IWRS) in 1:1 ratio (Placebo: Hylan G-F 20). |
Arm/Group Title | Placebo | Hylan G-F 20 |
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Participants received a single intra-articular (IA) injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. | Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. |
Period Title: Overall Study | ||
Started | 220 | 220 |
Treated | 220 | 218 |
Completed | 219 | 212 |
Not Completed | 1 | 8 |
Reason Not Completed | ||
Poor compliance to protocol | 0 | 1 |
Withdraw before treatment | 1 | 5 |
Randomized but not treated | 0 | 2 |
Baseline Characteristics
Arm/Group Title | Placebo | Hylan G-F 20 | Total | |
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Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. | Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 220 | 220 | 440 | |
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Analysis was performed on randomized population which consisted of all participants with a treatment kit number allocated and recorded in IVRS/IWRS database, and regardless of whether the treatment kit was used or not.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 220 participants | 220 participants | 440 participants | |
61.6 (7.8) | 61.5 (7.9) | 61.5 (7.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 220 participants | 220 participants | 440 participants | |
Female |
172 78.2%
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170 77.3%
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342 77.7%
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Male |
48 21.8%
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50 22.7%
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98 22.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 220 participants | 220 participants | 440 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
220 100.0%
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220 100.0%
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440 100.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
0 0.0%
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0 0.0%
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0 0.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi aventis recherche & développement |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi ( Genzyme, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT03190369 |
Other Study ID Numbers: |
EFC12723 U1111-1131-0507 ( Other Identifier: UTN ) |
First Submitted: | June 14, 2017 |
First Posted: | June 16, 2017 |
Results First Submitted: | January 19, 2020 |
Results First Posted: | February 5, 2020 |
Last Update Posted: | March 25, 2022 |