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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1167-6813 | Other Identifier | World Health Organization |
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Primary Objective:
To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).
Secondary Objective:
To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synvisc-One | Experimental | Single 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore [measurement of pain while walking on flat surface] between 40-80 mm, measured on a 0-100 mm scale with 0 represents no pain and 100 represents worst possible pain) at Week 26, 39 or 52 (Repeat treatment). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synvisc-One | Drug | intraarticular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC A1 Subscore at Week 26 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. | Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC A1 Subscore at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. | Baseline, Week 52 (missing data imputed by LOCF) |
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Inclusion Criteria:
Male and female participant aged 30 years or older, with active lifestyle.
The participant must be able to read, understand, and sign an informed consent form, understand requirements for followup visits, and must be willing to provide information at the scheduled evaluations.
The participant had a diagnosis of OA of the target knee confirmed by recent X-ray (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence [KL] Grade I-III), predominant in the tibiofemoral compartment.
WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or severe walking pain) in the target knee.
Participants with bilateral disease may be included in the study with the below strict conditions:
If female, must had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females must had been surgically sterile or postmenopausal (as documented in the 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 |
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The study was conducted at 36 sites in India between February 16, 2010 and September 7, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synvisc-One | Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52 ) when measured on a 0-100 mm scale, where higher score indicate higher pain. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change From Baseline in WOMAC A Score at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. | Baseline, Week 52 (missing data imputed by LOCF) |
| Change From Baseline in WOMAC B Score at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. | Baseline, Week 52 (missing data imputed by LOCF) |
| Change From Baseline in WOMAC C Score at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. | Baseline, Week 52 (missing data imputed by LOCF) |
| Patient Global Assessment (PTGA) Score at Week 52 | PTGA (global 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. Number of participants with different categories of PTGA score at Week 52 are reported. | Week 52 (missing data imputed by LOCF) |
| Clinician Observer Global Assessment (COGA) Score at Week 52 | COGA (global 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 the physician to rate participant's osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported. | Week 52 (missing data imputed by LOCF). |
| 12-Item Short Form Health Survey (SF-12) | SF-12 health survey is a self-reported questionnaire to measure participant's profile of functional health and well-being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported. | Baseline, Week 26, 52 |
| Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52 | 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 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported. | Baseline up to Week 52 |
| Time Between Initial and Repeat Synvisc-One Treatment | Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection. | Baseline up to Week 52 |
| Change From Baseline in WOMAC A1 Subscore After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
| Change From Baseline in WOMAC A Score After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
| Change From Baseline in WOMAC B Score After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
| Change From Baseline in WOMAC C Score After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
| Participants Received Repeat Injection |
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| COMPLETED |
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| NOT COMPLETED |
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Intent to treat (ITT) population included all participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Synvisc-One | Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number of participants analysed for this parameter were 392. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Height | Mean | Standard Deviation | centimeters |
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| Body Mass Index | Mean | Standard Deviation | kilogram per square meter |
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| 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 WOMAC A1 Subscore at Week 26 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. | ITT population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]). |
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| Secondary | Change From Baseline in WOMAC A1 Subscore at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. | ITT population. Number of participants analyzed=participants with baseline and Week 52 data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 (missing data imputed by LOCF) |
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| Secondary | Change From Baseline in WOMAC A Score at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. | ITT population. Number of participants analyzed=participants with baseline and Week 52 data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 (missing data imputed by LOCF) |
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| Secondary | Change From Baseline in WOMAC B Score at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. | ITT population. Number of participants analyzed=participants with baseline and Week 52 data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 (missing data imputed by LOCF) |
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| Secondary | Change From Baseline in WOMAC C Score at Week 52 | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. | ITT population. Number of participants analyzed=participants with baseline and Week 52 data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 (missing data imputed by LOCF) |
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| Secondary | Patient Global Assessment (PTGA) Score at Week 52 | PTGA (global 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. Number of participants with different categories of PTGA score at Week 52 are reported. | ITT population. Number of participants analyzed=participants with baseline and Week 52 data. | Posted | Number | participants | Week 52 (missing data imputed by LOCF) |
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| Secondary | Clinician Observer Global Assessment (COGA) Score at Week 52 | COGA (global 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 the physician to rate participant's osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported. | ITT population. Number of participants analyzed=participants with baseline and Week 52 data. | Posted | Number | participants | Week 52 (missing data imputed by LOCF). |
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| Secondary | 12-Item Short Form Health Survey (SF-12) | SF-12 health survey is a self-reported questionnaire to measure participant's profile of functional health and well-being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported. | ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively. | Posted | Number | participants | Baseline, Week 26, 52 |
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| Secondary | Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52 | 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 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported. | ITT population. Number of participants analysed = participants with baseline and Week 52 data. | Posted | Number | participants | Baseline up to Week 52 |
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| Secondary | Time Between Initial and Repeat Synvisc-One Treatment | Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection. | ITT population. Number of participants analysed = participants from ITT population who received repeat injection. | Posted | Mean | Standard Deviation | weeks | Baseline up to Week 52 |
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| Secondary | Change From Baseline in WOMAC A1 Subscore After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
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| Secondary | Change From Baseline in WOMAC A Score After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
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| Secondary | Change From Baseline in WOMAC B Score After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Repeat intent to treat population. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
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| Secondary | Change From Baseline in WOMAC C Score After Repeat Injection | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). | Repeat intent to treat population. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) |
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All Adverse Events (AE) were collected from signature of the informed consent form up to the final follow up visit (up to Week 56) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (From First dose of study drug until the end of study period). Analysis performed on safety population included all participants treated in the study. Data was planned to be reported for systemic and local adverse events separately.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synvisc-One: Systemic Adverse Event | Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint. | 5 | 394 | 23 | 394 | ||
| EG001 | Synvisc-One: Local Adverse Event | Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. Local adverse events were defined as any adverse event which occurred in the treated joint. | 1 | 394 | 22 | 394 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Cervical myelopathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Myelomalacia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Radiculopathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact --US@Sanofi.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C049816 | hylan |
Not provided
Not provided
Not provided
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