- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01091116
A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS (ALBATROSS)
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Bad Doberan, Allemagne, 18209
- Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
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Berlin, Allemagne, 10117
- Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
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Berlin, Allemagne, 12247
- Orthopädische Praxis Dr. Wagenitz
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Bochum, Allemagne, 44787
- ClinPharm International, Prüfzentrum Bochum
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Dresden, Allemagne, 01067
- ClinPharm International, Prüfzentrum Dresden
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Erlangen, Allemagne, 91054
- Medizinische Klinik 3, Universität Erlangen-Nürnberg
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Frankfurt, Allemagne, 60596
- ClinPharm Prüfzentrum Frankfurt / aM
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Görlitz, Allemagne, 02826
- ClinPharm Prüfzentrum Görlitz
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Hamburg, Allemagne, 22143
- Clinical Research Hamburg
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Hamburg, Allemagne, 22767
- Orthopädie Zentrum Altona
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Leipzig, Allemagne, 04103
- ClinPharm International, Prüfzentrum Leipzig
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Magdeburg, Allemagne, 39104
- ClinPharm Prüfzentrum Magdeburg
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Bilbao, Espagne, 48013
- Servicio de Reumatologia, Hospital de Basurto
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Madrid, Espagne, 28046
- Servicio de Reumatologia, Hospital Universitario La Paz
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Sabadell, Espagne, 08208
- Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
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Sevilla, Espagne, 41009
- Servicio de Reumatologia, Hospital Universitario Virgen Macarena
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Orléans, France, 45000
- Centre Hospitalier Régional - Hôpital Porte Madeleine
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Paris, France, 75181
- Hôtel Dieu - GHU Ouest
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Toulouse, France, 31300
- Department of Rheumatology, Purpan University Hospital
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Bologna, Italie, 40138
- Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
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Firenze, Italie, 50139
- Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
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Pisa, Italie, 56126
- Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
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Siena, Italie, 53100
- Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Double dose MEN16132 0.125 mg
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
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Intra-articular administration of two low doses of MEN16132 at 2-week interval.
Autres noms:
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Expérimental: Double dose MEN16132 0.25 mg
Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.
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Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
Autres noms:
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Expérimental: Double dose MEN16132 0.5 mg
Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.
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Intra-articular injection of two high doses of MEN16132 at 2-week interval
Autres noms:
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Autres noms:
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Expérimental: 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.
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Intra-articular injection of two high doses of MEN16132 at 2-week interval
Autres noms:
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Autres noms:
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Comparateur placebo: Placebo
Intra-articular administration of two doses of Placebo at 2-week interval.
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Intra-articular injection of 2 doses of Placebo control at 2-week interval
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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WOMAC VA 3.1 A Score (Total Pain)
Délai: over the 3 weeks after the first administration
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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WOMAC VA 3.1.B Score (Knee Stiffness)
Délai: up to 3 months after first dose
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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
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WOMAC VA 3.1. C Score (Function)
Délai: up to 3 months after first dose
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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
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Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria
Délai: up to 3 months after first dose
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Osteoarthritis Research Society International (OARSI). Response defined as:
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
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Patient Global Assessment
Délai: up to 3 months after first dose
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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
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WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]
Délai: over the 3 weeks after the first administration
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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
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WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]
Délai: over the 3 weeks after the first administration
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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
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Adverse Event Reports
Délai: up to 4 months after screening
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Incidence of spontaneously reported adverse events
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up to 4 months after screening
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Clinically Significant Abnormal Laboratory Tests
Délai: up to 4 months from screening
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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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Karel Pavelka, Prof MD, Institute of Rheumatology, Charles University Prague
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Arthrite
- Arthrose
- Arthrose, Genou
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents immunosuppresseurs
- Facteurs immunologiques
- Compléter les agents inactivants
- Antagonistes des récepteurs de la bradykinine B2
- Antagonistes des récepteurs de la bradykinine
- (4-amino-5-(4-(4-(2,4-dichloro-3-(2,4-diméthyl-8-quinolyloxyméthyl)phénylsulfonamido)tétrahydro-2H-4-pyranoylcarbonyl)pipérazino)-5-oxopentyle) (triméthyl)ammonium
Autres numéros d'identification d'étude
- BKOS-02
- 2009-014918-99 (Numéro EudraCT)
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