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A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS (ALBATROSS)

16 de enero de 2013 actualizado por: Menarini Group

Intra-articular Treatment With MEN16132 in Patients With Symptomatic Primary Osteoarthritis of the Knee: A Randomized, Multi-centre, Double Blind, Placebo Controlled, Five Parallel Group, Dose Finding Study

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo, as well the time to onset and duration of effect.

Tipo de estudio

Intervencionista

Inscripción (Actual)

423

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Doberan, Alemania, 18209
        • Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
      • Berlin, Alemania, 10117
        • Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
      • Berlin, Alemania, 12247
        • Orthopädische Praxis Dr. Wagenitz
      • Bochum, Alemania, 44787
        • ClinPharm International, Prüfzentrum Bochum
      • Dresden, Alemania, 01067
        • ClinPharm International, Prüfzentrum Dresden
      • Erlangen, Alemania, 91054
        • Medizinische Klinik 3, Universität Erlangen-Nürnberg
      • Frankfurt, Alemania, 60596
        • ClinPharm Prüfzentrum Frankfurt / aM
      • Görlitz, Alemania, 02826
        • ClinPharm Prüfzentrum Görlitz
      • Hamburg, Alemania, 22143
        • Clinical Research Hamburg
      • Hamburg, Alemania, 22767
        • Orthopädie Zentrum Altona
      • Leipzig, Alemania, 04103
        • ClinPharm International, Prüfzentrum Leipzig
      • Magdeburg, Alemania, 39104
        • ClinPharm Prüfzentrum Magdeburg
  • España
      • Bilbao, España, 48013
        • Servicio de Reumatologia, Hospital de Basurto
      • Madrid, España, 28046
        • Servicio de Reumatologia, Hospital Universitario La Paz
      • Sabadell, España, 08208
        • Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
      • Sevilla, España, 41009
        • Servicio de Reumatologia, Hospital Universitario Virgen Macarena
  • Francia
      • Orléans, Francia, 45000
        • Centre Hospitalier Régional - Hôpital Porte Madeleine
      • Paris, Francia, 75181
        • Hôtel Dieu - GHU Ouest
      • Toulouse, Francia, 31300
        • Department of Rheumatology, Purpan University Hospital
  • Italia
      • Bologna, Italia, 40138
        • Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
      • Firenze, Italia, 50139
        • Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
      • Pisa, Italia, 56126
        • Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
      • Siena, Italia, 53100
        • Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Main Inclusion Criteria:

  • Male or female patients ≥40 years old.
  • Symptomatic primary knee osteoarthritis (ACR criteria) since ≥6 months prior to screening, Kellgren Lawrence Grade 2 or 3, and representing an indication for intra-articular drug injection.
  • >50 mm VAS pain score assigned to the index knee at WOMAC VA 3.1-A1 (pain while walking on a flat surface).
  • >125 mm VAS pain score assigned to the index knee at WOMAC VA 3.1 A subscore (total pain).
  • Pain in the index knee on at least 50% of the days in the month preceding the screening.

Main Exclusion Criteria:

  • Patients with Kellgren & Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
  • Knee condition representing an indication for surgery
  • Patients with Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
  • Patients with isolated patella-femoral syndrome or chondromalacia.
  • Patients with OA predominant in the lateral compartment or any significant valgus deformity.
  • Patients with any other disease or condition interfering with the free use and evaluation of the index knee for the 3 month duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis).
  • Major injury or surgery to the index knee within the previous 12 months prior to screening.
  • Severe hip osteoarthritis ipsilateral to index knee.
  • Any pain >30 mm VAS that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
  • Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation or likely to be changed during the duration of the study
  • Use of systemic or topical corticosteroids >10 mg prednisolone equivalent per day during 30 days prior to randomisation.
  • Use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics) during 1 or 2 weeks prior to randomisation.
  • Any intra-articular or local periarticular punction, injection or surgery to the index knee during the 6 months prior to screening.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Double dose MEN16132 0.125 mg
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
Droga: MEN16132 - 0.125 mg
Intra-articular administration of two low doses of MEN16132 at 2-week interval.
Otros nombres:
  • fasitibant 0.125 mg
Experimental: Double dose MEN16132 0.25 mg
Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.
Droga: MEN16132 - 0.25 mg
Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
Otros nombres:
  • fasitibant 0.25 mg
Experimental: Double dose MEN16132 0.5 mg
Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.
Droga: MEN16132 - 0.5 mg
Intra-articular injection of two high doses of MEN16132 at 2-week interval
Otros nombres:
  • fasitibant 0.5 mg
Droga: MEN16132 - 0.5 mg
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Otros nombres:
  • fasitibant 0.5 mg
Experimental: Single dose MEN16132 0.5 mg
Intra-articular administration of one 0.5 mg dose of MEN16132 followed by one intra-articular injection of placebo at 2-week interval.
Droga: MEN16132 - 0.5 mg
Intra-articular injection of two high doses of MEN16132 at 2-week interval
Otros nombres:
  • fasitibant 0.5 mg
Droga: MEN16132 - 0.5 mg
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Otros nombres:
  • fasitibant 0.5 mg
Comparador de placebos: Placebo
Intra-articular administration of two doses of Placebo at 2-week interval.
Droga: Placebo
Intra-articular injection of 2 doses of Placebo control at 2-week interval

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
WOMAC VA 3.1 A Score (Total Pain)
Periodo de tiempo: over the 3 weeks after the first administration

Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours.

The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain).

A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.

The change from baseline was assessed along 3 weeks after first drug administrations.
over the 3 weeks after the first administration

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
WOMAC VA 3.1.B Score (Knee Stiffness)
Periodo de tiempo: up to 3 months after first dose

WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).

A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness.

The change at Week 13 from baseline is reported.
up to 3 months after first dose
WOMAC VA 3.1. C Score (Function)
Periodo de tiempo: up to 3 months after first dose

Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours.

The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).

A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities.

WOMAC VA 3.1.C scores at baseline and at Week 13 are reported.
up to 3 months after first dose
Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria
Periodo de tiempo: up to 3 months after first dose

Osteoarthritis Research Society International (OARSI).

Response defined as:

  • a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale
  • OR if two of the following three findings are recorded:

a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient's global assessment by 20% or more and by 10 or more points on the scale.
up to 3 months after first dose
Patient Global Assessment
Periodo de tiempo: up to 3 months after first dose

Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm).

Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0).

A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms.
up to 3 months after first dose
WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]
Periodo de tiempo: over the 3 weeks after the first administration

Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.

A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
over the 3 weeks after the first administration
WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]
Periodo de tiempo: over the 3 weeks after the first administration

Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.

A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
over the 3 weeks after the first administration
Adverse Event Reports
Periodo de tiempo: up to 4 months after screening
Incidence of spontaneously reported adverse events
up to 4 months after screening
Clinically Significant Abnormal Laboratory Tests
Periodo de tiempo: up to 4 months from screening

Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators.

The following hematochemical and urinary parameters were analysed:

Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin.
up to 4 months from screening

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Menarini Group

Investigadores

  • Investigador principal: Karel Pavelka, Prof MD, Institute of Rheumatology, Charles University Prague

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2010

Finalización primaria (Actual)

1 de febrero de 2011

Finalización del estudio (Actual)

1 de marzo de 2011

Fechas de registro del estudio

Enviado por primera vez

18 de marzo de 2010

Primero enviado que cumplió con los criterios de control de calidad

19 de marzo de 2010

Publicado por primera vez (Estimar)

23 de marzo de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de febrero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

16 de enero de 2013

Última verificación

1 de enero de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BKOS-02
  • 2009-014918-99 (Número EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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