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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1129-3321 | Other Identifier | UTN | |
| EFC13912 | Other Identifier | Sanofi |
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Primary Objective:
Secondary Objectives:
Duration of study period for each participants was 26-28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synvisc | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylan G-F 20 | Drug | Intra-articular injection (pre-filled glass syringe) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26 | 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. | Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]) |
| Overview of Adverse Events (AE) | 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. | Up to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12 | 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. | Baseline, Week 8 and Week 12 (missing data imputed by LOCF) |
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Inclusion criteria :
The participants had a diagnosis of OA of the Target Knee confirmed by recent X-Ray (mild to moderate joint space narrowing and/or osteophytes predominant in the tibiofemoral compartment)
WOMAC A1 baseline 100 mm Visual Analog Score (VAS) between 40-80 mm (moderate or severe walking pain) in the Target knee
Participants with bilateral disease included in the study with the below strict conditions:
Pre-menopausal female participants had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females had been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Shanghai | China |
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).
The study was conducted at 10 centers in China. A total of 237 participants were enrolled between March 09, 2012 and February 28, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synvisc | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Synvisc | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26 | 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. | 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). | Posted | Mean | Standard Deviation | mm | Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]) |
|
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.
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synvisc | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 22 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C049816 | hylan |
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| Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26 | 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. | Baseline, Week 8, 12 and 26 (missing data imputed by LOCF) |
| Patient Global Assessment (PTGA) Score | 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. | Baseline, Week 8, 12 and 26 (missing data imputed by LOCF) |
| Clinical Observer Global Assessment (COGA) Score | 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. | Baseline, Week 8, 12 and 26 (missing data imputed by LOCF) |
| Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26 | 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. | Baseline up to Week 26 |
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Overview of Adverse Events (AE) | 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. | Safety Set included all participants who received at least one injection of Synvisc. | Posted | Number | percentage of participants | Up to Week 26 |
|
|
|
| Secondary | Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12 | 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. | FAS population. | Posted | Mean | Standard Deviation | mm | Baseline, Week 8 and Week 12 (missing data imputed by LOCF) |
|
|
|
| Secondary | Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26 | 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. | FAS population. | Posted | Mean | Standard Deviation | mm | Baseline, Week 8, 12 and 26 (missing data imputed by LOCF) |
|
|
|
| Secondary | Patient Global Assessment (PTGA) Score | 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. | FAS population. | Posted | Number | percentage of participants | Baseline, Week 8, 12 and 26 (missing data imputed by LOCF) |
|
|
|
| Secondary | Clinical Observer Global Assessment (COGA) Score | 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. | FAS population. | Posted | Number | percentage of participants | Baseline, Week 8, 12 and 26 (missing data imputed by LOCF) |
|
|
|
| Secondary | Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26 | 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. | FAS population. | Posted | Number | percentage participants | Baseline up to Week 26 |
|
|
|
| 4 |
| 237 |
| 66 |
| 237 |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Meniscal Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Amyasthenia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Gouty Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Extremitiess Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vertebral Disc Prolapsed | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Hand Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Infectious Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Pain in the Area of Injection Site | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Weakness | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Swelling in the Area of Injection Site | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Warmth | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Joint Effusion in the Area of Injection Site | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Astriction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Colonic Polyp | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Atrophic Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Ligament Spain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Meniscal Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Extremities Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Humeral Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Night Sweat | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Contact Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Migraine | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Cramp | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Colporrhagia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Retinal Hemorrhage | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
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.
| Title | Measurements |
|---|---|
|
| Treatment-emergent AEs Lead to Discontinuation |
|
|
| WOMAC B: Change from baseline at Week 8 |
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| WOMAC B: Change from baseline at Week 12 |
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| WOMAC B: Change from baseline at Week 26 |
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| WOMAC C: Change from baseline at Week 8 |
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| WOMAC C: Change from baseline at Week 12 |
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| WOMAC C: Change from baseline at Week 26 |
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| Title | Measurements |
|---|---|
|
| Baseline: Poor |
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| Baseline: Very Poor |
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| Week 8: Very Well |
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| Week 8: Well |
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| Week 8: Fair |
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| Week 8 : Poor |
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| Week 8: Very Poor |
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| Week 12: Very Well |
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| Week 12: Well |
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| Week 12: Fair |
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| Week 12: Poor |
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| Week 12: Very Poor |
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| Week 26: Very Well |
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| Week 26: Well |
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| Week 26: Fair |
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| Week 26: Poor |
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| Week 26: Very Poor |
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| Title | Measurements |
|---|---|
|
| Baseline: Poor |
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| Baseline: Very Poor |
|
| Week 8: Very Well |
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| Week 8: Well |
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| Week 8: Fair |
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| Week 8: Poor |
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| Week 8: Very Poor |
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| Week 12: Very Well |
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| Week 12: Well |
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| Week 12: Fair |
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| Week 12: Poor |
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| Week 12: Very Poor |
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| Week 26: Very Well |
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| Week 26: Well |
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| Week 26: Fair |
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| Week 26: Poor |
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| Week 26: Very Poor |
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| Title | Measurements |
|---|---|
|
| Missing |
|