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A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00131352
Recruitment Status : Completed
First Posted : August 18, 2005
Results First Posted : January 19, 2012
Last Update Posted : April 3, 2015
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoarthritis, Knee
Musculoskeletal Diseases
Interventions Device: hylan G-F 20
Other: Phosphate Buffered Saline
Enrollment 253
Recruitment Details  
Pre-assignment Details 329 participants enrolled and 76 screening failures. One participant was randomised to the Synvisc group but received Saline in error; counted in the Saline group for safety analyses (Safety population) and in the Synvisc group for efficacy analyses (Intent-to-treat population) in both study periods.
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period. Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
Period Title: Initial Treatment Period
Started 123 [1] 130 [1]
Intent to Treat Population 124 129
Completed 114 118
Not Completed 9 12
Reason Not Completed
Adverse Event             1             3
Non-compliant             1             2
Withdrawal by Subject             1             1
Lack of Efficacy             6             4
Other             0             2
[1]
Safety population
Period Title: Repeat Treatment Period
Started 160 [1] 0
Completed 158 0
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Other             1             0
[1]
Safety population: 77 Synvisc + 83 Saline Control participants from the Initial Treatment period.
Arm/Group Title Synvisc Saline Control Total
Hide Arm/Group Description Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline. Total of all reporting groups
Overall Number of Baseline Participants 124 129 253
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 129 participants 253 participants
63.6  (9.64) 62.5  (9.17) 63.0  (9.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 129 participants 253 participants
Female
92
  74.2%
88
  68.2%
180
  71.1%
Male
32
  25.8%
41
  31.8%
73
  28.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 124 participants 129 participants 253 participants
Caucasian 118 125 243
Black 5 3 8
Hispanic 0 0 0
Asian 0 1 1
Other 1 0 1
1.Primary Outcome
Title Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
Hide Description The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.
Time Frame Day 0, up to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 124 129
Mean (Standard Error)
Unit of Measure: units on a scale
-0.84  (0.060) -0.69  (0.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.
2.Secondary Outcome
Title Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
Hide Description The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.
Time Frame Day 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population.
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 124 129
Mean (Standard Error)
Unit of Measure: units on a scale
-0.76  (0.07) -0.58  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Hide Description Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 115 117
Measure Type: Number
Unit of Measure: participants
None 17 13
Mild 45 39
Moderate 41 42
Severe 11 19
Extreme 1 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Generalized Estimating Equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.35 to 0.92
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
Hide Description The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
Time Frame Day 0, up to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population.
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 124 129
Mean (Standard Error)
Unit of Measure: units on a scale
-0.66  (0.061) -0.63  (0.059)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
Hide Description The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
Time Frame Day 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population.
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 124 129
Mean (Standard Error)
Unit of Measure: units on a scale
-0.59  (0.076) -0.48  (0.074)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Hide Description The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 115 117
Measure Type: Number
Unit of Measure: participants
Very Well 9 2
Well 33 27
Fair 50 54
Poor 21 31
Very Poor 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Generalized Estimating Equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.31 to 0.82
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
Hide Description The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 115 117
Measure Type: Number
Unit of Measure: participants
Very Well 13 8
Well 37 31
Fair 38 38
Poor 22 34
Very Poor 5 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Generalized Estimating Equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.34 to 0.93
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26
Hide Description

Participants were classified as a positive responder if at least one of the following two conditions were met:

  1. A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR
  2. Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population.
Arm/Group Title Synvisc Saline Control
Hide Arm/Group Description:
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
Overall Number of Participants Analyzed 123 129
Measure Type: Number
Unit of Measure: participants
Responder - meets OMERACT-OARSI criteria 73 66
NonResponder -does not meet OMERACT-OARSI criteria 43 52
NonResponder - Withdrew Before Study Completion 7 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc, Saline Control
Comments Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method Generalized Estimating Equations (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.41 to 1.16
Estimation Comments [Not Specified]
Time Frame Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
 
Arm/Group Title Synvisc - Initial Treatment Period Saline Control - Initial Treatment Period Synvisc - Repeat Treatment Period Synvisc (From Saline Control) - Repeat Treatment Period
Hide Arm/Group Description Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26). Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period. Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30). Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
All-Cause Mortality
Synvisc - Initial Treatment Period Saline Control - Initial Treatment Period Synvisc - Repeat Treatment Period Synvisc (From Saline Control) - Repeat Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Synvisc - Initial Treatment Period Saline Control - Initial Treatment Period Synvisc - Repeat Treatment Period Synvisc (From Saline Control) - Repeat Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/123 (4.07%)   3/130 (2.31%)   0/77 (0.00%)   2/83 (2.41%) 
Cardiac disorders         
Angina pectoris  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Atrial fibrillation  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Bradycardia  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Sinus arrest  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Gastrointestinal disorders         
Inguinal hernia  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
General disorders         
Hernia  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Non-cardiac chest pain  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Prostate cancer  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Transitional cell carcinoma  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Nervous system disorders         
Radial nerve palsy  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Synvisc - Initial Treatment Period Saline Control - Initial Treatment Period Synvisc - Repeat Treatment Period Synvisc (From Saline Control) - Repeat Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   70/123 (56.91%)   77/130 (59.23%)   9/77 (11.69%)   11/83 (13.25%) 
Cardiac disorders         
Arrhythmia  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Sinus arrhythmia  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Constipation  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Diarrhoea  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Gastritis  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Hiatus hernia  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Nausea  1  0/123 (0.00%)  2/130 (1.54%)  0/77 (0.00%)  0/83 (0.00%) 
Toothache  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Vomiting  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
General disorders         
Gait disturbance  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Hernia  1  1/123 (0.81%)  0/130 (0.00%)  1/77 (1.30%)  0/83 (0.00%) 
Influenza like illness  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Injection site haematoma  1  0/123 (0.00%)  0/130 (0.00%)  1/77 (1.30%)  0/83 (0.00%) 
Injection site pain  1  1/123 (0.81%)  1/130 (0.77%)  1/77 (1.30%)  2/83 (2.41%) 
Malaise  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Oedema peripheral  1  0/123 (0.00%)  2/130 (1.54%)  0/77 (0.00%)  0/83 (0.00%) 
Pyrexia  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Infections and infestations         
Bronchitis  1  2/123 (1.63%)  3/130 (2.31%)  2/77 (2.60%)  0/83 (0.00%) 
Cellulitis  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Cystitis  1  2/123 (1.63%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Dental caries  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Erysipelas  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Herpes zoster  1  1/123 (0.81%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Herpes zoster ophthalmic  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Infected insect bite  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Influenza  1  4/123 (3.25%)  7/130 (5.38%)  0/77 (0.00%)  1/83 (1.20%) 
Lower respiratory tract infection  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  1/83 (1.20%) 
Mastitis  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Nasopharyngitis  1  5/123 (4.07%)  7/130 (5.38%)  0/77 (0.00%)  0/83 (0.00%) 
Oral fungal infection  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Pharyngitis  1  3/123 (2.44%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Pharyngitis bacterial  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Respiratory tract infection  1  3/123 (2.44%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Sinusitis  1  2/123 (1.63%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Upper respiratory tract infection  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Urinary tract infection  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Viral infection  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Fall  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Hand fracture  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Joint dislocation  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Post-traumatic pain  1  3/123 (2.44%)  3/130 (2.31%)  0/77 (0.00%)  0/83 (0.00%) 
Procedural pain  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Thermal burn  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Investigations         
Heart rate increased  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Helicobacter pylori identification test positive  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  32/123 (26.02%)  30/130 (23.08%)  4/77 (5.19%)  2/83 (2.41%) 
Arthritis  1  1/123 (0.81%)  0/130 (0.00%)  1/77 (1.30%)  0/83 (0.00%) 
Arthropathy  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Back pain  1  8/123 (6.50%)  10/130 (7.69%)  0/77 (0.00%)  0/83 (0.00%) 
Bone pain  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Bursitis  1  0/123 (0.00%)  0/130 (0.00%)  1/77 (1.30%)  0/83 (0.00%) 
Exostosis  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Joint effusion  1  7/123 (5.69%)  7/130 (5.38%)  0/77 (0.00%)  0/83 (0.00%) 
Joint range of motion decreased  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Joint stiffness  1  10/123 (8.13%)  13/130 (10.00%)  1/77 (1.30%)  0/83 (0.00%) 
Joint swelling  1  5/123 (4.07%)  7/130 (5.38%)  0/77 (0.00%)  1/83 (1.20%) 
Joint warmth  1  2/123 (1.63%)  5/130 (3.85%)  0/77 (0.00%)  0/83 (0.00%) 
Muscle spasms  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Musculoskeletal chest pain  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Neck pain  1  1/123 (0.81%)  3/130 (2.31%)  0/77 (0.00%)  0/83 (0.00%) 
Osteitis  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Osteoarthritis  1  0/123 (0.00%)  3/130 (2.31%)  0/77 (0.00%)  0/83 (0.00%) 
Pain in extremity  1  1/123 (0.81%)  3/130 (2.31%)  0/77 (0.00%)  0/83 (0.00%) 
Periarthritis  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Rotator cuff syndrome  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Shoulder pain  1  4/123 (3.25%)  2/130 (1.54%)  0/77 (0.00%)  0/83 (0.00%) 
Spinal disorder  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Spinal osteoarthritis  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Synovial cyst  1  0/123 (0.00%)  2/130 (1.54%)  0/77 (0.00%)  2/83 (2.41%) 
Tendon disorder  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Nervous system disorders         
Carpal tunnel syndrome  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Cervical root pain  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Dizziness  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Headache  1  9/123 (7.32%)  15/130 (11.54%)  0/77 (0.00%)  0/83 (0.00%) 
Hypoaesthesia  1  0/123 (0.00%)  0/130 (0.00%)  0/77 (0.00%)  1/83 (1.20%) 
Migraine  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Nerve compression  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Paraesthesia  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Sciatica  1  2/123 (1.63%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Syncope vasovagal  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Trigeminal neuralgia  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Psychiatric disorders         
Depressed mood  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Depression  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Insomnia  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Panic attack  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Stress  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Cough  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Pharyngolaryngeal pain  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Pneumonitis  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Sinus disorder  1  1/123 (0.81%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus generalised  1  0/123 (0.00%)  1/130 (0.77%)  0/77 (0.00%)  0/83 (0.00%) 
Vascular disorders         
Hypertension  1  2/123 (1.63%)  0/130 (0.00%)  0/77 (0.00%)  0/83 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
In multi-site studies, principal investigator (PI) can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00131352     History of Changes
Other Study ID Numbers: SYNV00704
First Submitted: August 17, 2005
First Posted: August 18, 2005
Results First Submitted: August 3, 2009
Results First Posted: January 19, 2012
Last Update Posted: April 3, 2015