Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
To compare long term disease modifiying and symptomatic effects at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondroitin sulfate (Condrosan) | Experimental | CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning |
|
| Celecoxib | Active Comparator | CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondroitin sulfate | Drug | Chondroitin sulphate 1200 mg/day, 24 months treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cartilage Volume Loss of the Lateral Compartment | To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily. | 12 months (Day 364) and 24 months (Day 728) |
| Measure | Description | Time Frame |
|---|---|---|
| Cartilage Volume Loss of the Global Knee | To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months. | 12 months (Day 364) and 24 months (Day 728) |
| Cartilage Volume in the Medial Compartment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Pelletier, MD | Principal Author | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Rhumatologie de Montréal | Montreal | Quebec | H2L-1S6 | Canada | ||
| Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28728606 | Derived | Martel-Pelletier J, Raynauld JP, Mineau F, Abram F, Paiement P, Delorme P, Pelletier JP. Levels of serum biomarkers from a two-year multicentre trial are associated with treatment response on knee osteoarthritis cartilage loss as assessed by magnetic resonance imaging: an exploratory study. Arthritis Res Ther. 2017 Jul 20;19(1):169. doi: 10.1186/s13075-017-1377-y. | |
| 27809891 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chondroitin Sulfate (Condrosan) | CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period |
| FG001 | Celecoxib (Celebrex) | CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning Celecoxib: Celecoxib 200 mg/day, 24 months treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chondroitin Sulfate (Condrosan) | CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period |
| BG001 | Celecoxib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cartilage Volume Loss of the Lateral Compartment | To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily. | Intention-To-Treat | Posted | Mean | Standard Deviation | cubic milimeters | 12 months (Day 364) and 24 months (Day 728) |
|
2 years
Not provided
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 | Chondroitin Sulfate (Condrosan) | CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marta Herrero - Clinical R&D Manager | Bioiberica | +34934904908 | mherrero@bioiberica.com |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002809 | Chondroitin Sulfates |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D002807 | Chondroitin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Celecoxib | Drug | Celecoxib 200 mg/day, 24 months treatment period |
|
To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.
| 12 months (Day 364) and 24 months (Day 728) |
| Synovial Membrane Thickness | To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Bone Marrow Lesions Score | To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:
| Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Synovial Fluid Volume | To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Percentage of Participants With the Presence of Extrusion in the Meniscus | The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Visual Analog Scale (VAS) | Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: "Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line". Left hand marker represents "No pain" and right hand marker represents "The worst pain imaginable". | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| WOMAC Pain Subscale | Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| WOMAC Stiffness Subscale | Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| WOMAC Function Subscale | Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Short Form (SF-36) Health Survey | The SF-36 is composed of 35 items measuring:
The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Percentage of Participants With Presence of Joint Swelling and Effusion | Study knees were evaluated at each visit for the presence or absence of swelling and effusion. | Baseline, 12 months (Day 364) and 24 months (Day 728) |
| Use of Acetaminophen | Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit. Daily consumption of acetaminophen was calculated as an average. | 3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728) |
| Montreal |
| Quebec |
| J1H-5N4 |
| Canada |
| Groupe de Recherche en rhumatologie et maladies osseoues | Québec | Quebec | G1V-3M7 | Canada |
| Centre de Rhumatologie St. Louis | Sante Foi | Quebec | G1W-4R4 | Canada |
| Centre de Recherche musculo-squellettique | Trois-Rivières | Quebec | G8A-1Y2 | Canada |
| Pelletier JP, Raynauld JP, Beaulieu AD, Bessette L, Morin F, de Brum-Fernandes AJ, Delorme P, Dorais M, Paiement P, Abram F, Martel-Pelletier J. Chondroitin sulfate efficacy versus celecoxib on knee osteoarthritis structural changes using magnetic resonance imaging: a 2-year multicentre exploratory study. Arthritis Res Ther. 2016 Nov 3;18(1):256. doi: 10.1186/s13075-016-1149-0. |
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning Celecoxib: Celecoxib 200 mg/day, 24 months treatment period |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Cartilage Volume in the Lateral Compartment | Mean | Standard Deviation | cubic milimeters |
|
| Cartilage Volume in the Medial Compartment | Mean | Standard Deviation | cubic milimeters |
|
| Cartilage Volume in the Global Knee | Mean | Standard Deviation | cubic milimeters |
|
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Celecoxib: Celecoxib 200 mg/day, 24 months treatment period
|
|
| Secondary | Cartilage Volume Loss of the Global Knee | To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months. | Intention-to-Treat | Posted | Mean | Standard Deviation | cubic milimeters | 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Cartilage Volume in the Medial Compartment | To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months. | Intention-To-Treat | Posted | Mean | Standard Deviation | cubic milimeters | 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Synovial Membrane Thickness | To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial. | Intention-To-Treat | Posted | Mean | Standard Deviation | milimeters | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Bone Marrow Lesions Score | To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:
| Intention-To-Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Synovial Fluid Volume | To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months. | Intention-To-Treat | Posted | Mean | Standard Deviation | mililiters | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Percentage of Participants With the Presence of Extrusion in the Meniscus | The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus. | Intention-To-Treat | Posted | Number | percentage of participants | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Visual Analog Scale (VAS) | Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: "Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line". Left hand marker represents "No pain" and right hand marker represents "The worst pain imaginable". | Intention-To-Treat | Posted | Mean | Standard Deviation | centimeters | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | WOMAC Pain Subscale | Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively. | Intention-To-Treat | Posted | Mean | Standard Deviation | centimeters | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | WOMAC Stiffness Subscale | Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively. | Intention-To-Treat | Posted | Mean | Standard Deviation | centimeters | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | WOMAC Function Subscale | Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively. | Intention-To-Treat | Posted | Mean | Standard Deviation | centimeters | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Short Form (SF-36) Health Survey | The SF-36 is composed of 35 items measuring:
The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. | Intention-To-Treat | Posted | Median | Standard Deviation | Scores on a scales | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Percentage of Participants With Presence of Joint Swelling and Effusion | Study knees were evaluated at each visit for the presence or absence of swelling and effusion. | Intention-To-Treat | Posted | Number | percentage of participants | Baseline, 12 months (Day 364) and 24 months (Day 728) |
|
|
|
| Secondary | Use of Acetaminophen | Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit. Daily consumption of acetaminophen was calculated as an average. | Intention-To-Treat | Posted | Mean | Standard Deviation | Daily number of caplets taken | 3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728) |
|
|
|
| 10 |
| 97 |
| 78 |
| 97 |
| EG001 | Celecoxib | CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning Celecoxib: Celecoxib 200 mg/day, 24 months treatment period | 6 | 97 | 79 | 97 |
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Morganella Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Lip And/Or Oral Cavity Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Cataract Operation | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
|
| Hip Surgery | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Diverticular Perforation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Proctocolitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Post Procedural Haematuria | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Urinary Retention Postoperative | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sinus Arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bladder Perforation | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
Not provided
| D012216 |
| Rheumatic Diseases |
| D000096926 |
| Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Visit 9 (Day 728) |
|
| Global Knee - Visit 9 (Day 728) |
|
| Visit 9 (Day 728) |
|
| Visit 9 (Day 728) Medial meniscus |
|
| Visit 2 (Baseline) Lateral meniscus |
|
| Visit 6 (Day 364) Lateral meniscus |
|
| Visit 9 (Day 728) Lateral meniscus |
|
| Visit 9 (Day 728) |
|
| Visit 9 (Day 728) |
|
| Visit 9 (Day 728) |
|
| Visit 9 (Day 728) |
|
| Visit 9 (Day 728) Physical Component Summary |
|
| Visit 2 (Baseline) Mental Component Summary |
|
| Visit 6 (Day 364) Mental Component Summary |
|
| Visit 9 (Day 728) Mental Component Summary |
|