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A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

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ClinicalTrials.gov Identifier: NCT01618708
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis, Hip
Interventions Device: Synvisc-One (hylan G-F 20)
Device: Placebo
Enrollment 357
Recruitment Details The study was conducted at 42 centers in the US and Canada. A total of 1113 participants were screened between 05 September 2012 and 21 November 2014.
Pre-assignment Details Of 1113 screened participants, 33 were re-screened, 357 were randomized and 741 were screen failures. Screen failures were mainly due to inclusion criteria not met and exclusion criteria met.
Arm/Group Title Placebo Synvisc-One
Hide Arm/Group Description Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period. Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Period Title: Overall Study
Started 175 182
Treated 172 180
Completed 131 136
Not Completed 44 46
Reason Not Completed
Adverse Event             10             10
Lost to Follow-up             3             3
Withdrawal by Subject             17             22
Lack of Efficacy             8             8
Technical problems             2             0
Other than specified above             1             1
Randomized but not treated             3             2
Arm/Group Title Placebo Synvisc-One Total
Hide Arm/Group Description Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period. Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period. Total of all reporting groups
Overall Number of Baseline Participants 175 182 357
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who received study medication or part of the treatment administration.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 182 participants 357 participants
59.8  (8.8) 60.8  (10.0) 60.3  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 182 participants 357 participants
Female
105
  60.0%
106
  58.2%
211
  59.1%
Male
70
  40.0%
76
  41.8%
146
  40.9%
1.Primary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
Hide Description WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (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 represents lower pain and higher score represents higher pain.
Time Frame From baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Synvisc-One
Hide Arm/Group Description:
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Overall Number of Participants Analyzed 175 182
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.26  (0.17) -2.19  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Synvisc-One
Comments Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.7462
Comments Threshold for significance at 0.05 level
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.38 to 0.52
Estimation Comments Placebo vs Synvisc-One
2.Secondary Outcome
Title Change From Baseline in WOMAC A Score Over 26 Weeks
Hide Description WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
Time Frame From Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Synvisc-One
Hide Arm/Group Description:
Single 6 mL IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Overall Number of Participants Analyzed 175 182
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.26  (0.16) -2.19  (0.16)
3.Secondary Outcome
Title Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
Hide Description PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.
Time Frame From baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Synvisc-One
Hide Arm/Group Description:
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Overall Number of Participants Analyzed 175 182
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.06  (0.17) -2.00  (0.16)
4.Secondary Outcome
Title Percentage of WOMAC A1 Responder Over 26 Weeks
Hide Description WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.
Time Frame From Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Synvisc-One
Hide Arm/Group Description:
Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
Overall Number of Participants Analyzed 175 182
Measure Type: Number
Unit of Measure: Percentage of participants
45.71 45.05
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 any AE that started during or after the first dose of study drug. Safety population defined as all randomized participants who received any study drug or part of treatment administration.
 
Arm/Group Title Placebo Synvisc-One
Hide Arm/Group Description Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period. Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
All-Cause Mortality
Placebo Synvisc-One
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Synvisc-One
Affected / at Risk (%) Affected / at Risk (%)
Total   15/172 (8.72%)   10/180 (5.56%) 
Cardiac disorders     
Atrial fibrillation  1  0/172 (0.00%)  1/180 (0.56%) 
Cardiac failure congestive  1  0/172 (0.00%)  1/180 (0.56%) 
Myocardial infarction  1  0/172 (0.00%)  1/180 (0.56%) 
Congenital, familial and genetic disorders     
Intracranial lipoma  1  1/172 (0.58%)  0/180 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  0/172 (0.00%)  1/180 (0.56%) 
General disorders     
Non-cardiac chest pain  1  1/172 (0.58%)  0/180 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  1/172 (0.58%)  0/180 (0.00%) 
Cholecystitis acute  1  1/172 (0.58%)  0/180 (0.00%) 
Injury, poisoning and procedural complications     
Humerus fracture  1  0/172 (0.00%)  1/180 (0.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/172 (2.33%)  0/180 (0.00%) 
Back pain  1  0/172 (0.00%)  1/180 (0.56%) 
Joint stiffness  1  1/172 (0.58%)  0/180 (0.00%) 
Osteoarthritis  1  4/172 (2.33%)  2/180 (1.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1  0/172 (0.00%)  1/180 (0.56%) 
Pancreatic carcinoma  1  1/172 (0.58%)  0/180 (0.00%) 
Prostate cancer  1  0/172 (0.00%)  1/180 (0.56%) 
Psychiatric disorders     
Anxiety  1  0/172 (0.00%)  1/180 (0.56%) 
Confusional state  1  1/172 (0.58%)  0/180 (0.00%) 
Disorientation  1  1/172 (0.58%)  0/180 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/172 (0.58%)  0/180 (0.00%) 
Pulmonary mass  1  1/172 (0.58%)  0/180 (0.00%) 
Surgical and medical procedures     
Obesity surgery  1  1/172 (0.58%)  0/180 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Synvisc-One
Affected / at Risk (%) Affected / at Risk (%)
Total   33/172 (19.19%)   43/180 (23.89%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  20/172 (11.63%)  32/180 (17.78%) 
Nervous system disorders     
Headache  1  14/172 (8.14%)  13/180 (7.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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 ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01618708     History of Changes
Other Study ID Numbers: SYNV04910
EFC12791 ( Other Identifier: Sanofi )
First Submitted: June 11, 2012
First Posted: June 13, 2012
Results First Submitted: May 31, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016