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

16 de janeiro de 2013 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

423

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Double dose MEN16132 0.125 mg
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
Medicamento: MEN16132 - 0.125 mg
Intra-articular administration of two low doses of MEN16132 at 2-week interval.
Outros nomes:
  • 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.
Medicamento: MEN16132 - 0.25 mg
Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
Outros nomes:
  • 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.
Medicamento: MEN16132 - 0.5 mg
Intra-articular injection of two high doses of MEN16132 at 2-week interval
Outros nomes:
  • fasitibant 0.5 mg
Medicamento: MEN16132 - 0.5 mg
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Outros nomes:
  • 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.
Medicamento: MEN16132 - 0.5 mg
Intra-articular injection of two high doses of MEN16132 at 2-week interval
Outros nomes:
  • fasitibant 0.5 mg
Medicamento: MEN16132 - 0.5 mg
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Outros nomes:
  • fasitibant 0.5 mg
Comparador de Placebo: Placebo
Intra-articular administration of two doses of Placebo at 2-week interval.
Medicamento: Placebo
Intra-articular injection of 2 doses of Placebo control at 2-week interval

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
WOMAC VA 3.1 A Score (Total Pain)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
WOMAC VA 3.1.B Score (Knee Stiffness)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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]
Prazo: 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]
Prazo: 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
Prazo: up to 4 months after screening
Incidence of spontaneously reported adverse events
up to 4 months after screening
Clinically Significant Abnormal Laboratory Tests
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Menarini Group

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2010

Conclusão Primária (Real)

1 de fevereiro de 2011

Conclusão do estudo (Real)

1 de março de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

18 de março de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de março de 2010

Primeira postagem (Estimativa)

23 de março de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de fevereiro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de janeiro de 2013

Última verificação

1 de janeiro de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

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