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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 assess the efficacy of a combination of chondroitin sulphate and glucosamine sulphate manufactured by Tedec-Meiji Farma, S.A. compared with placebo in patients with osteoarthritis of the knee. |
Valorar la eficacia de la asociación de condroitín sulfato y glucosamina sulfato fabricada por Tedec-Meiji Farma, S.A. comparada frente a placebo en pacientes con artrosis de rodilla. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety of treatment. |
Valorar la seguridad del tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient aged at 45 or more years old, of both sexes. Primary knee OA according to ACR criteria. Osteoarthritis radiological grade II-III according to Kellgren and Lawrence scale. Patients with moderate-severe pain (from 40-80 mm) in Visual Analogue Scale (VAS) during last week of the most symptomatic knee. Patient able to understand and follow study procedures, also to willingness to adhere to treatment. Patient who agrees to participate in the study by giving his/her written informed consent. |
Paciente de 45 o más años de edad, de ambos sexos. Artrosis primaria de rodilla de acuerdo con criterios ACR. Grado radiológico de artrosis II-III según la escala Kellgren y Lawrence. Pacientes con dolor moderado a severo (de 40-80 mm) en la Escala Visual Analógica (EVA) durante la semana previa a la evaluación en la rodilla más sintomática. Paciente con capacidad para comprender y seguir los procedimientos del estudio y disposición para adherirse al estudio. Conformidad para participar en el estudio otorgando su consentimiento por escrito. |
|
E.4 | Principal exclusion criteria |
Overweight (body mass index greater than or equal 35). Pregnant or lactating women. Women of child-bearing age not using effective contraception. Predominant patellofemoral disease. Patients with clinical significant trauma or surgery in the target knee. Administration of NSAIDs within the 14 days prior to the inclusion in the study. Administration of any intra-articular treatment, glucosamine sulphate, chondroitin sulphate and/or diacerein within the 3 months prior to their inclusion in the study. Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy. Pain in other parts of the body greater than the knee pain that could interfere with the evaluation. Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral or fungal infections. Clinical diagnosis established of uncontrolled diabetes mellitus, with fasting glucose greater than 126 mg. Patients with asthma. Any pathology that could interfere with the administration or assessment. History of hypersensitivity to any excipients or pharmacological product. Patients awaiting surgery. Patients awaiting disablement assessment. Previous participation in this protocol. |
Sobrepeso (Índice de Masa Corporal mayor o igual a 35). Embarazo o lactancia. Mujeres en edad fértil que no utilicen anticonceptivos eficaces. Enfermedad patelofemoral predominante. Pacientes con trauma clínicamente relevante o cirugía en la rodilla seleccionada. Administración de AINEs durante los 14 días previos a la inclusión en el estudio. Administración de cualquier tratamiento intraarticular glucosamina sulfato, condroitín sulfato y/o diacereína durante los 3 meses previos a la inclusión en el estudio. Enfermedades reumáticas recurrentes (antecedentes y/o signos actuales) que pudieran confundir o interferir con la evaluación de eficacia en el dolor. Dolor localizado en una parte del cuerpo diferente de la rodilla seleccionada que pudiera interferir con la evaluación. Sujetos con infección aguda o crónica activa que requieran tratamiento antibiótico, o enfermedad vírica severa o infecciones fúngicas. Diagnóstico clínico de diabetes mielitus no controlada, con valores de glucosa en ayunas mayores de 126 mg. Pacientes con asma. Cualquier patología que pudiera interferir con el desarrollo del estudio o la valoración. Pacientes con sensibilidad o intolerancia a los fármacos en estudio o cualquiera de sus excipientes. Pacientes en lista de espera para cirugía. Pacientes en situación de demanda por incapacidad. Participación previa en este protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of pain in Visual Analogue Scale (0-100 mm) at the end of treatment. Success will be considered as an absolute difference of 10 points at the end of treatment between chondroitin sulfate+glucosamine sulfate group and placebo group. |
Reducción del dolor en la Escala Visual Analógica (0-100 mm) al final del tratamiento. Se considerará como éxito una diferencia absoluta de 10 puntos al final del tratamiento entre el grupo de condroitín sulfato+glucosamina sulfato y el grupo placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months (end of treatment period). |
6 meses (final del periodo de tratamiento). |
|
E.5.2 | Secondary end point(s) |
OMERACT-OARSI responder criteria (and corresponding subscales), WOMAC score with the use of 0-100 mm VAS, Global Investigator Assessment and the consumption of rescue medication. |
Criterios de respuesta OMERACT-OARSI (y sus correspondientes subescalas), puntuación del índice WOMAC mediante el uso de la EVA 0-100 mm, Valoración Global del Investigador y consumo de medicación de rescate. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3 and 6 months during treatment. |
1, 3 y 6 meses durante el tratamiento. |
|
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Prospectivo, multicéntrico. |
Prospective, multicentre. |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
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 | Yes |
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
|
LVLS |
Última visita del último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |