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Trial record 1 of 1 for:    SYNVIL06244
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A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)

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ClinicalTrials.gov Identifier: NCT01586338
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis
Intervention Drug: Hylan G-F 20
Enrollment 237
Recruitment Details The study was conducted at 10 centers in China. A total of 237 participants were enrolled between March 09, 2012 and February 28, 2013.
Pre-assignment Details Of 237 enrolled participants 232 participants were treated. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).
Arm/Group Title Synvisc
Hide Arm/Group Description Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Period Title: Overall Study
Started 237
Completed 229
Not Completed 8
Reason Not Completed
Adverse Event             3
Lost to Follow-up             1
Withdrawal by participant             3
Other             1
Arm/Group Title Synvisc
Hide Arm/Group Description Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Baseline Participants 237
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 237 participants
62.9  (9.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 237 participants
Female
183
  77.2%
Male
54
  22.8%
1.Primary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
Hide Description WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Time Frame Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 232
Mean (Standard Deviation)
Unit of Measure: mm
-33.0  (17.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance = 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Synvisc
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Sign Rank Test
Comments [Not Specified]
2.Primary Outcome
Title Overview of Adverse Events (AE)
Hide Description An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the ‘on treatment period’ (from first dose of study drug until the end of study period). Category "AE" included participant with both serious and non-serious AE.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set included all participants who received at least one injection of Synvisc.
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 237
Measure Type: Number
Unit of Measure: percentage of participants
AEs 27.8
Treatment-emergent AEs 27.8
Treatment-emergent SAEs 1.7
Treatment-emergent AEs Lead to Discontinuation 0.4
3.Secondary Outcome
Title Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
Hide Description WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Time Frame Baseline, Week 8 and Week 12 (missing data imputed by LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population.
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 232
Mean (Standard Deviation)
Unit of Measure: mm
Change form baseline at Week 8 -26.0  (17.68)
Change form baseline at Week 12 -30.0  (17.43)
4.Secondary Outcome
Title Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
Hide Description WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.
Time Frame Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population.
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 232
Mean (Standard Deviation)
Unit of Measure: mm
WOMAC A: Change from baseline at Week 8 -92.7  (71.77)
WOMAC A: Change from baseline at Week 12 -109.8  (73.68)
WOMAC A: Change from baseline at Week 26 -121.5  (77.18)
WOMAC B: Change from baseline at Week 8 -28.9  (37.53)
WOMAC B: Change from baseline at Week 12 -34.6  (38.44)
WOMAC B: Change from baseline at Week 26 -36.6  (39.75)
WOMAC C: Change from baseline at Week 8 -270.0  (252.86)
WOMAC C: Change from baseline at Week 12 -325.9  (258.57)
WOMAC C: Change from baseline at Week 26 -358.4  (270.48)
5.Secondary Outcome
Title Patient Global Assessment (PTGA) Score
Hide Description PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.
Time Frame Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population.
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 232
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: Very Well 0.0
Baseline: Well 1.3
Baseline: Fair 29.3
Baseline: Poor 60.3
Baseline: Very Poor 9.1
Week 8: Very Well 4.3
Week 8: Well 41.8
Week 8: Fair 46.1
Week 8 : Poor 6.9
Week 8: Very Poor 0.9
Week 12: Very Well 5.2
Week 12: Well 44.4
Week 12: Fair 44.0
Week 12: Poor 6.0
Week 12: Very Poor 0.4
Week 26: Very Well 8.2
Week 26: Well 46.6
Week 26: Fair 37.1
Week 26: Poor 7.8
Week 26: Very Poor 0.4
6.Secondary Outcome
Title Clinical Observer Global Assessment (COGA) Score
Hide Description COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.
Time Frame Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population.
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 232
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: Very Well 0.0
Baseline: Well 1.7
Baseline: Fair 35.3
Baseline: Poor 57.3
Baseline: Very Poor 5.6
Week 8: Very Well 5.2
Week 8: Well 42.7
Week 8: Fair 41.8
Week 8: Poor 9.9
Week 8: Very Poor 0.4
Week 12: Very Well 7.3
Week 12: Well 44.4
Week 12: Fair 41.8
Week 12: Poor 6.0
Week 12: Very Poor 0.4
Week 26: Very Well 9.5
Week 26: Well 47.4
Week 26: Fair 35.3
Week 26: Poor 7.8
Week 26: Very Poor 0.0
7.Secondary Outcome
Title Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Hide Description Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population.
Arm/Group Title Synvisc
Hide Arm/Group Description:
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Overall Number of Participants Analyzed 232
Measure Type: Number
Unit of Measure: percentage participants
Required Less Use of Other Therapies 2.2
Required More Use of Other Therapies 3.0
Required No Change in Use of Other Therapies 93.1
Missing 1.7
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the time of signing the informed consent until completion of the study).
 
Arm/Group Title Synvisc
Hide Arm/Group Description Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
All-Cause Mortality
Synvisc
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Synvisc
Affected / at Risk (%)
Total   4/237 (1.69%) 
Injury, poisoning and procedural complications   
Meniscal Injury  1  1/237 (0.42%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  1/237 (0.42%) 
Arthropathy  1  1/237 (0.42%) 
Arthralgia  1  1/237 (0.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Synvisc
Affected / at Risk (%)
Total   66/237 (27.85%) 
Cardiac disorders   
Atrial Fibrillation  2  1/237 (0.42%) 
Ear and labyrinth disorders   
Vertigo  2  1/237 (0.42%) 
Eye disorders   
Retinal Hemorrhage  2  1/237 (0.42%) 
Gastrointestinal disorders   
Astriction  2  1/237 (0.42%) 
Gingivitis  2  1/237 (0.42%) 
Abdominal Pain  2  1/237 (0.42%) 
Diarrhea  2  1/237 (0.42%) 
Colonic Polyp  2  1/237 (0.42%) 
Atrophic Gastritis  2  1/237 (0.42%) 
Toothache  2  1/237 (0.42%) 
Gastritis  2  3/237 (1.27%) 
General disorders   
Pain in the Area of Injection Site  2  5/237 (2.11%) 
Weakness  2  2/237 (0.84%) 
Swelling in the Area of Injection Site  2  2/237 (0.84%) 
Warmth  2  1/237 (0.42%) 
Joint Effusion in the Area of Injection Site  2  1/237 (0.42%) 
Infections and infestations   
Upper Respiratory Tract Infection  2  17/237 (7.17%) 
Urinary Tract Infection  2  3/237 (1.27%) 
Herpes Zoster  2  1/237 (0.42%) 
Hand Infection  2  1/237 (0.42%) 
Infectious Pneumonia  2  1/237 (0.42%) 
Injury, poisoning and procedural complications   
Ligament Spain  2  4/237 (1.69%) 
Meniscal Injury  2  1/237 (0.42%) 
Extremities Injury  2  1/237 (0.42%) 
Humeral Fracture  2  1/237 (0.42%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  22/237 (9.28%) 
Back Pain  2  2/237 (0.84%) 
Joint Swelling  2  2/237 (0.84%) 
Osteoarthritis  2  1/237 (0.42%) 
Musculoskeletal Pain  2  1/237 (0.42%) 
Arthropathy  2  1/237 (0.42%) 
Amyasthenia  2  1/237 (0.42%) 
Spondyloarthropathy  2  1/237 (0.42%) 
Gouty Arthritis  2  1/237 (0.42%) 
Extremitiess Pain  2  1/237 (0.42%) 
Vertebral Disc Prolapsed  2  1/237 (0.42%) 
Psychiatric disorders   
Migraine  2  1/237 (0.42%) 
Dizziness  2  1/237 (0.42%) 
Cramp  2  1/237 (0.42%) 
Reproductive system and breast disorders   
Colporrhagia  2  1/237 (0.42%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal Pain  2  1/237 (0.42%) 
Skin and subcutaneous tissue disorders   
Night Sweat  2  1/237 (0.42%) 
Contact Dermatitis  2  1/237 (0.42%) 
Papule  2  1/237 (0.42%) 
Urticaria  2  1/237 (0.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 22
2
Term from vocabulary, MedDRA 15.0
Certain Agreements
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01586338     History of Changes
Other Study ID Numbers: SYNVIL06244
U1111-1129-3321 ( Other Identifier: UTN )
EFC13912 ( Other Identifier: Sanofi )
First Submitted: April 23, 2012
First Posted: April 26, 2012
Results First Submitted: January 27, 2016
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016