E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Knee osteoarthritis |
Artrosis de rodilla |
|
E.1.1.1 | Medical condition in easily understood language |
Knee osteoarthritis |
Artrosis de rodilla |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of PRGF ®-Endoret ® in patients with knee osteoarthritis, by means of combination of intraosseous with intraarticular injections. |
Evaluar la eficacia y seguridad del PRGF®-Endoret® en pacientes con artrosis de rodilla, combinando infiltraciones intraóseas con infiltraciones intraarticulares. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate systemic effect of PRGF ®-Endoret ® in patients with knee osteoarthritis, by means of combination of intraosseous with intraarticular injections. |
Evaluar el efecto ssitemico del PRGF®-Endoret® en pacientes con artrosis de rodilla, combinando infiltraciones intraóseas con infiltraciones intraarticulares. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes aged between 40 and 85 years old. Diagnosed with osteoarthritis predominantly in the medial tibiofemoral compartment through X-ray knee clinical study. Joint pain than or equal to 2.5 points in VAS. Radiological severity grades 1, 2, 3, 4 according to the Ahlbäck scale. Values of Body Mass Index between 20 and 35. Serological tests negative against syphilis, HIV, HBV and HCV. Possibility for observation during the monitoring period Signed informed consent |
Pacientes de ambos sexos con edades comprendidas entre los 40 y los 85 años. Diagnosticados de artrosis con predominio en el compartimento tibio-femoral interna de rodilla mediante estudio clínico radiológico. Dolor en la articulación igual o superior a 2,5 puntos en EAV. Severidad radiológica grados 1, 2, 3, 4 según la escala Ahlbäck. Valores de Índice de Masa Corporal entre 20 y 35. Pruebas serológicas negativas frente a sífilis, VIH, VHB y VHC. Posibilidad para observación durante el periodo de seguimiento Firma del consentimiento informado |
|
E.4 | Principal exclusion criteria |
Gonarthrosis requiring infiltration in both knees BMI> 35 Mechanical deformity requiring osteotomy. Previous arthroscopy in the last year. Intra-articular injection of hyaluronic acid in the last 6 months. Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). Poorly controlled diabetes (glycosylated hemoglobin above 9%) Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9). It is undergoing immunosuppressive treatments. Treatment with steroids during the 6 months prior to inclusion in the study. Patients unable to stop treatment with NSAIDs during the study. Pregnancy and lactation. Polyarticular disease diagnosed. |
Gonartrosis que requiera infiltración en ambas rodillas Índice de masa corporal>35 Deformidad mecánica que requiera osteotomía. Artroscopia previa en el último año. Infiltración intraarticular de ácido hialurónico en los 6 últimos meses. Enfermedad reumática autoinmune sistémica (enfermedades del tejido conectivo y vasculitis necrotizantes sistémicas). Diabetes Mellitus mal controlada (hemoglobina glicosilada superior al 9%) Alteraciones hematológicas (trombopatía, trombopenia, anemias con Hb<9). Estar siendo sometido a tratamientos inmunosupresores. Tratamiento mediante corticoides durante los 6 meses anteriores a su inclusión en el estudio. Pacientes que no puedan abandonar el tratamiento con AINES durante el estudio. Embarazo o lactancia. Enfermedad poliarticular diagnosticada. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinically significant pain improvement according to KOOS scale (Knee injury and Osteoarthritis Outcome Score) |
Mejoría dolor clínicamente significativa KOOS (Knee injury and Osteoarthritis Outcome Score) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Symptom improvement clinically significant (KOOS). Improved performance of daily activities clinically significant (KOOS). Improved performance of sport activites clinically significant (KOOS). Improved quality of life clinically significant (KOOS). |
Mejoría de los síntomas clínicamente significativa (KOOS). Mejoría desempeño de las actividades cotidianas clínicamente significativa (KOOS). Mejoría desempeño de las actividades deportivas y recretativas clínicamente significativa (KOOS). Mejoría de la calidad de vida clínicamente significativa (KOOS). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |