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This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.
Cartilage repair currently remains a problematic orthopedic concern with no effective solution. The development of new surgical techniques or therapies is critical in meeting this medical need.
This Canadian trial will be a pivotal protocol study, conducted as a randomized, controlled trial. A total of 80 subjects, 40 subjects in each of the two groups (BST-CarGel applied to a microfractured lesion or microfracture alone), will be enrolled in this study. The subjects and investigative medical staff will not be blinded to treatment due to the difference in surgical incision size. However, although the treatment will not be blinded, the primary effectiveness assessment will be blinded. The primary endpoint of this study will be cartilage repair at 12 months proved by demonstrating that BST-CarGel treatment effectively fills cartilage lesions with high quality cartilaginous tissue. The secondary endpoints will be pain, stiffness and function while other tertiary endpoints will include safety, quality-of-life (QOL), as well as macroscopic characterizations of tissue repair. The primary measure of this study will occur at 12 months, when imaging of repair tissue using magnetic resonance (MR) and associated analyses will compare tissue volume, quality and other anatomical variables. Radiographic evaluations will be blinded. Volunteer biopsies at 13 months may be obtained. Pain, stiffness, function and QOL will be assessed prior to treatment, and at 3, 6 and 12 months following treatment using self-administered validated scores (WOMAC and SF-36). In addition, subject safety will be assessed through a record of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfracture with BST-CarGel | Experimental | BST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle |
|
| Microfracture without BST-CarGel | Active Comparator | Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BST-CarGel with Microfracture | Device | Microfracture performed with BST-CarGel added to the treated defect |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI. | Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences. | 12 months |
| Repair Cartilage T2 Relaxation Time | Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C) | The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Stanish, MD | Orthopaedic and Sport Medicine - Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Medicine Centre - University of Calgary | Calgary | Alberta | T2N 1N4 | Canada | ||
| New West Sports Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16322617 | Background | Hoemann CD, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive MS, Buschmann MD. Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects. J Bone Joint Surg Am. 2005 Dec;87(12):2671-2686. doi: 10.2106/JBJS.D.02536. | |
| 17008111 | Background | Chevrier A, Hoemann CD, Sun J, Buschmann MD. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis Cartilage. 2007 Mar;15(3):316-27. doi: 10.1016/j.joca.2006.08.007. Epub 2006 Sep 26. |
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Subjects were stratified by site and lesion type (acute/chronic) to address possible repair differences. Final eligibility and lesion type were determined during diagnostic arthroscopy at treatment visit, subjects were randomized to BST-CarGel or MFX treatment using a computer-generated randomization schedule to ensure a 1:1 ratio within each site.
Subjects were recruited from May 04, 2006 to January 2009 from orthopaedic surgeon referrals across 24 centers across Canada, Europe, and South Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | BST-CarGel applied to a Microfractured lesion |
| FG001 | Control | Microfracture alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Microfracture without BST-CarGel | Procedure | Microfracture performed without BST-CarGel added to the treated defect. |
|
| 12 months |
| Frequency of Adverse Events Between Study Groups | 12 months |
| New Westminster |
| British Columbia |
| V3L 5P5 |
| Canada |
| Hospital at UBC | Vancouver | British Columbia | V6T 1Z3 | Canada |
| Pan Am Clinic | Winnipeg | Manitoba | R3M 3E4 | Canada |
| Orthopaedic and Sport Medicine Clinic of Nova Scotia | Halifax | Nova Scotia | B3H 4M2 | Canada |
| Entralogix Clinical Group Inc. | Newmarket | Ontario | V6T 2B5 | Canada |
| Sports Medicine Clinic - Carleton University | Ottawa | Ontario | K1S 5B6 | Canada |
| Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery | Toronto | Ontario | M3N 3M5 | Canada |
| Hopital Charles LeMoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hospital Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier | Québec | Quebec | G1J 1Z4 | Canada |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Kyung Hee University Medical Center | Seoul | 130-702 | South Korea |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Gregorio Maraňón | Madrid | Madrid | 28034 | Spain |
| Hospital La Paz | Madrid | Madrid | Spain |
| FREMAP Centro de Prevención y Rehabilitación | Majadahonda | Madrid | 28220 | Spain |
| Hospital Begona de Gijon | Gijón | Principality of Asturias | 33204 | Spain |
| 16895758 | Background | Hoemann CD, Sun J, McKee MD, Chevrier A, Rossomacha E, Rivard GE, Hurtig M, Buschmann MD. Chitosan-glycerol phosphate/blood implants elicit hyaline cartilage repair integrated with porous subchondral bone in microdrilled rabbit defects. Osteoarthritis Cartilage. 2007 Jan;15(1):78-89. doi: 10.1016/j.joca.2006.06.015. Epub 2006 Aug 8. |
| 24048551 | Result | Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | BST-CarGel applied to a Microfractured lesion |
| BG001 | Control | Microfracture alone |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI. | Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences. | Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total) | Posted | Least Squares Mean | Standard Error | Percentage of lesion fill | 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Repair Cartilage T2 Relaxation Time | Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body). | Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total) | Posted | Least Squares Mean | Standard Error | milliseconds | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C) | The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. | Secondary efficacy was evaluated based on pain, stiffness, and function, as well as the macroscopic nature of the cartilage repair. Measurements of pain, stiffness, and function were made at 3, 6, and 12 months post-treatment using the WOMAC questionnaire and SF-36v2. WORMS scoring was conducted on 12-month post-treatment MRI scans. | Posted | Least Squares Mean | Standard Error | Units on a scale | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Adverse Events Between Study Groups | AEs will be coded and tabulated separately by system organ class (SOC) and individual preferred terms (PTs). The number and percentage of subjects who experienced AEs will be summarized in decreasing frequency by using the medical dictionary for regulatory activities (MedDRA) dictionary. | Posted | Number | Percentage of participants | 12 months |
|
|
AEs were reported through out the study from signed Informed Consent up to 12 months post-treatment.
Only subjects randomized to BST-CarGel® treatment were exposed to the investigational device.
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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 | Experimental | BST-CarGel applied to a Microfractured lesion | 5 | 41 | 40 | 41 | ||
| EG001 | Control | Microfracture alone | 1 | 39 | 36 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment | Subject experienced pulmonary embolism. Drug therapy administered at onset, and subject recovered. All SAEs, onset of pulmonary emboli secondary to DVT and pleurisy post-treatment, considered related to the procedure and possibly related to device. |
|
| deep vein thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment | Deep vein thrombosis,classified - severe. Drug therapy administered at onset, and subject recovered.All SAEs, onset of pulmonary emboli secondary to DVT and pleurisy, post-treatment, considered related to the procedure and possibly related to device. |
|
| pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment | Pleurisy associated to pulmonary embolism. Severe, sequelae of main SAE. Pleurisy not treated w/medication, subject recovered. All SAEs, onset of pulmonary emboli secondary to DVT and pleurisy, considered related to procedure and possibly to device. |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment | Subject experienced wheezing of moderate severity. Drug therapy administered at the onset of the SAE, and the subject recovered. The SAE, onset at same day post-treatment, was considered to be related to the procedure but not related to the device. |
|
| chest pain | General disorders | MedDRA (11.1) | Systematic Assessment | Subject experienced chest pain of moderate severity. Drug therapy was administered at the onset of the SAE, and the subject recovered. The SAE, onset at Day 346 post-treatment, was considered to be unrelated to the procedure. |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment | Subject experienced diarrhea;classified as severe. Drug therapy was administered at the onset of the SAE, and the subject recovered. The SAE, onset at Day 151 post-treatment, was considered to be unrelated to the procedure and the device. |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment | Subject experienced joint stiffness; classified as severe. Drug therapy was administered at the onset, and subject recovered with sequelae. The SAE, onset at Day 34 post-treatment, considered to be related to procedure but not related to the device. |
|
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment | Subject experienced joint ankylosis; classified as severe. Drug therapy was administered at onset, and subject recovered with sequelae. The SAE, onset at Day 93 post-treatment, considered possibly related to procedure but not related to the device. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| muscular spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| exostosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| hemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| myositis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| procedural pain | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| post-procedural nausea | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| burns second degree | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| epicondylitis | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| frostbite | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| hand fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| incision site complication | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| joint dislocation | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| joint injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| joint sprain | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| limb injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| post-procedural edema | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| seroma | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| tremor | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| balance disorder | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| burning sensation | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| carpal tunnel syndrome | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| complex regional pain syndrome | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| convulsion | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| disturbance in attention | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| hyperesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| loss of consciousness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| syncope vasovagal | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| chills | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| influenza-like illness | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| edema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| adverse drug reaction | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| drug intolerance | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| feeling hot | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| feeling of relaxation | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| injection site bruising | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| injection site pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| malaise | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| sinusitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| infected insect bite | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| clostridium colitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| escherichia infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| gastroenteritis viral | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| gingival infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| herpes zoster | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| laryngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| onychomycosis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| pharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| skin infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| stitch abscess | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| tinea pedis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| abdominal pain lower | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| crohn's disease | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pruritis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| acne | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| keloid scar | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| rosacea | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| seborrheic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| circulatory depression | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| deep vein thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| peripheral coldness | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| thrombophlebitis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| blood pressure decreased | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| blood pressure increased | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| body temperature increased | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| weight increased | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| hallucination | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| dysuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| polyuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Systematic Assessment |
| |
| drug hypersensitivity | Immune system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| podagra | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| cervical dysplasia | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
Disclosure restriction on the Institution/PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is > 60 days but ≤ 90 days from time submitted to sponsor for review. Sponsor can require changes to communication. Control over publication/presentation shall be extended for maximum of 2 years after termination of Trial, after which Institution/PI shall be free to publish/present without restraint.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Restrepo, MD, Director of Medical and Clinical Affairs | Piramal Healthcare (Canada) Limited | 450-686-2437 | 315 | alberto.restrepo@piramal.com |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
| >=65 years |
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| Male |
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| Spain |
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| Korea, Republic of |
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