- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
-
-
Bad Doberan, Duitsland, 18209
- Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
-
Berlin, Duitsland, 10117
- Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
-
Berlin, Duitsland, 12247
- Orthopädische Praxis Dr. Wagenitz
-
Bochum, Duitsland, 44787
- ClinPharm International, Prüfzentrum Bochum
-
Dresden, Duitsland, 01067
- ClinPharm International, Prüfzentrum Dresden
-
Erlangen, Duitsland, 91054
- Medizinische Klinik 3, Universität Erlangen-Nürnberg
-
Frankfurt, Duitsland, 60596
- ClinPharm Prüfzentrum Frankfurt / aM
-
Görlitz, Duitsland, 02826
- ClinPharm Prüfzentrum Görlitz
-
Hamburg, Duitsland, 22143
- Clinical Research Hamburg
-
Hamburg, Duitsland, 22767
- Orthopädie Zentrum Altona
-
Leipzig, Duitsland, 04103
- ClinPharm International, Prüfzentrum Leipzig
-
Magdeburg, Duitsland, 39104
- ClinPharm Prüfzentrum Magdeburg
-
-
-
-
-
Orléans, Frankrijk, 45000
- Centre Hospitalier Régional - Hôpital Porte Madeleine
-
Paris, Frankrijk, 75181
- Hôtel Dieu - GHU Ouest
-
Toulouse, Frankrijk, 31300
- Department of Rheumatology, Purpan University Hospital
-
-
-
-
-
Bologna, Italië, 40138
- Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
-
Firenze, Italië, 50139
- Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
-
Pisa, Italië, 56126
- Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
-
Siena, Italië, 53100
- Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena
-
-
-
-
-
Bilbao, Spanje, 48013
- Servicio de Reumatologia, Hospital de Basurto
-
Madrid, Spanje, 28046
- Servicio de Reumatologia, Hospital Universitario La Paz
-
Sabadell, Spanje, 08208
- Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
-
Sevilla, Spanje, 41009
- Servicio de Reumatologia, Hospital Universitario Virgen Macarena
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Double dose MEN16132 0.125 mg
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
|
Intra-articular administration of two low doses of MEN16132 at 2-week interval.
Andere namen:
|
Experimenteel: Double dose MEN16132 0.25 mg
Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.
|
Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
Andere namen:
|
Experimenteel: Double dose MEN16132 0.5 mg
Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.
|
Intra-articular injection of two high doses of MEN16132 at 2-week interval
Andere namen:
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Andere namen:
|
Experimenteel: 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.
|
Intra-articular injection of two high doses of MEN16132 at 2-week interval
Andere namen:
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
Andere namen:
|
Placebo-vergelijker: Placebo
Intra-articular administration of two doses of Placebo at 2-week interval.
|
Intra-articular injection of 2 doses of Placebo control at 2-week interval
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
WOMAC VA 3.1 A Score (Total Pain)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
WOMAC VA 3.1.B Score (Knee Stiffness)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: up to 3 months after first dose
|
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
|
Patient Global Assessment
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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
Tijdsspanne: up to 4 months after screening
|
Incidence of spontaneously reported adverse events
|
up to 4 months after screening
|
Clinically Significant Abnormal Laboratory Tests
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Karel Pavelka, Prof MD, Institute of Rheumatology, Charles University Prague
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Reumatische aandoeningen
- Artritis
- Artrose
- Artrose, knie
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Immunosuppressieve middelen
- Immunologische factoren
- Complementeer inactiverende middelen
- Bradykinine B2-receptorantagonisten
- Bradykinine-receptorantagonisten
- (4-amino-5-(4-(4-(2,4-dichloor-3-(2,4-dimethyl-8-chinolyloxymethyl)fenylsulfonamido)tetrahydro-2H-4-pyranoylcarbonyl)piperazino)-5-oxopentyl) (trimethyl)ammonium
Andere studie-ID-nummers
- BKOS-02
- 2009-014918-99 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Artrose, knie
-
ACE Running LLCAir ForceNog niet aan het werven
-
Smith & Nephew, Inc.VoltooidJourney II BCS Total Knee-systeemVerenigde Staten, België, Nieuw-Zeeland
-
Université Catholique de LouvainActief, niet wervend
-
Smith & Nephew, Inc.Nor Consult, LLCVoltooidJourney II XR Total Knee-systeemVerenigde Staten
-
Smith & Nephew, Inc.Nor ConsultVoltooidJourney II CR Total Knee-systeemVerenigde Staten
-
Cartiva, Inc.BeëindigdOSTEOARTHRITISVerenigde Staten
-
Federal University of Rio Grande do SulVoltooid
-
Jiangsu XinChen-Techfields Pharma Co., LTD.VoltooidKNIE OSTEOARTHRITISChina
-
Riphah International UniversityVoltooidRunner's KneePakistan
-
Federal University of São PauloVoltooidKNIE OSTEOARTHRITISBrazilië
Klinische onderzoeken op MEN16132 - 0.125 mg
-
SunovionVoltooidPediatrische aandachtstekortstoornis met hyperactiviteitVerenigde Staten
-
CelltrionNog niet aan het werven
-
Guangdong Zhongsheng Pharmaceutical Co., Ltd.VoltooidNiet-alcoholische steatohepatitis (NASH)China
-
Suzhou Alphamab Co., Ltd.Novotech (Australia) Pty LimitedWervingType 2 diabetesNieuw-Zeeland
-
Guangdong Zhongsheng Pharmaceutical Co., Ltd.VoltooidVaste tumor | Idiopathische longfibrose (IPF)China
-
Yungjin Pharm. Co., Ltd.VoltooidMELAS-syndroom | Mitochondriale ademhalingsketendeficiëntiesKorea, republiek van
-
Idorsia Pharmaceuticals Ltd.VoltooidSystemische lupus erythematosusSpanje, Verenigde Staten, Italië, Taiwan, Thailand, Polen, Russische Federatie, Israël, Oekraïne, Mexico, Filippijnen, Georgië, Verenigd Koninkrijk, Chili, Frankrijk, Bulgarije, Tsjechië, Griekenland, Hongarije, Roemenië, Kalkoen, ... en meer
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Nog niet aan het werven
-
Vigonvita Life SciencesVoltooidFarmacodynamische studie van TPN171H-tabletten bij patiënten met milde tot matige erectiestoornissenErectiestoornissenChina