Calendario›SNY›Hylan G-F 20
Hylan G-F 20
A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Ensayo de Sanofi en Artrosis.
Más ensayos de: Artrosis.
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 237
- Centros
- 1
- Fin del objetivo primario
- sep 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2012.
Qué mide
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26 (Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: * To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score * To evaluate the safety using the incidence, severity, seriousness, relatedness, and frequency of all treatment emergent Adverse Events (AEs) Secondary Objectives: * To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8, and 12 * To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26 * To evaluate the change in Patient Global Assessment (PTGA) score between baseline and weeks 8, 12 and 26 * To evaluate the change in Clinical Observer Global Assessment (COGA) score between baseline and weeks 8, 12 and 26 * To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and between baseline and weeks 1, 2, 8, 12 and 26
Más ensayos de SNY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01586338), actualizada en ene 2016.