- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Orléans, Francia, 45000
- Centre Hospitalier Régional - Hôpital Porte Madeleine
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Paris, Francia, 75181
- Hôtel Dieu - GHU Ouest
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Toulouse, Francia, 31300
- Department of Rheumatology, Purpan University Hospital
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Bad Doberan, Germania, 18209
- Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
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Berlin, Germania, 10117
- Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
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Berlin, Germania, 12247
- Orthopädische Praxis Dr. Wagenitz
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Bochum, Germania, 44787
- ClinPharm International, Prüfzentrum Bochum
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Dresden, Germania, 01067
- ClinPharm International, Prüfzentrum Dresden
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Erlangen, Germania, 91054
- Medizinische Klinik 3, Universität Erlangen-Nürnberg
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Frankfurt, Germania, 60596
- ClinPharm Prüfzentrum Frankfurt / aM
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Görlitz, Germania, 02826
- ClinPharm Prüfzentrum Görlitz
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Hamburg, Germania, 22143
- Clinical Research Hamburg
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Hamburg, Germania, 22767
- Orthopädie Zentrum Altona
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Leipzig, Germania, 04103
- ClinPharm International, Prüfzentrum Leipzig
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Magdeburg, Germania, 39104
- ClinPharm Prüfzentrum Magdeburg
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Bologna, Italia, 40138
- Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
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Firenze, Italia, 50139
- Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
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Pisa, Italia, 56126
- Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
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Siena, Italia, 53100
- Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena
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Bilbao, Spagna, 48013
- Servicio de Reumatologia, Hospital de Basurto
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Madrid, Spagna, 28046
- Servicio de Reumatologia, Hospital Universitario La Paz
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Sabadell, Spagna, 08208
- Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
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Sevilla, Spagna, 41009
- Servicio de Reumatologia, Hospital Universitario Virgen Macarena
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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
Altri nomi:
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Sperimentale: 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
Altri nomi:
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Altri nomi:
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Sperimentale: 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
Altri nomi:
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Altri nomi:
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Comparatore 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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WOMAC VA 3.1 A Score (Total Pain)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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WOMAC VA 3.1.B Score (Knee Stiffness)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Karel Pavelka, Prof MD, Institute of Rheumatology, Charles University Prague
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Artrite
- Osteoartrite
- Artrosi, ginocchio
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti inattivanti del complemento
- Antagonisti del recettore della bradichinina B2
- Antagonisti del recettore della bradichinina
- (4-ammino-5-(4-(4-(2,4-dicloro-3-(2,4-dimetil-8-chinolilossimetil)fenilsolfonammido)tetraidro-2H-4-piranoilcarbonil)piperazino)-5-ossopentil) (trimetil)ammonio
Altri numeri di identificazione dello studio
- BKOS-02
- 2009-014918-99 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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