A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

PHASE2CompletedINTERVENTIONAL
Enrollment

423

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

February 28, 2011

Study Completion Date

March 31, 2011

Conditions
Osteoarthritis, Knee
Interventions
DRUG

MEN16132 - 0.125 mg

Intra-articular administration of two low doses of MEN16132 at 2-week interval.

DRUG

MEN16132 - 0.25 mg

Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval

DRUG

MEN16132 - 0.5 mg

Intra-articular injection of two high doses of MEN16132 at 2-week interval

DRUG

MEN16132 - 0.5 mg

Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval

DRUG

Placebo

Intra-articular injection of 2 doses of Placebo control at 2-week interval

Trial Locations (23)

10117

Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte, Berlin

12247

Orthopädische Praxis Dr. Wagenitz, Berlin

18209

Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan, Bad Doberan

22143

Clinical Research Hamburg, Hamburg

22767

Orthopädie Zentrum Altona, Hamburg

28046

Servicio de Reumatologia, Hospital Universitario La Paz, Madrid

31300

Department of Rheumatology, Purpan University Hospital, Toulouse

39104

ClinPharm Prüfzentrum Magdeburg, Magdeburg

40138

Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli, Bologna

41009

Servicio de Reumatologia, Hospital Universitario Virgen Macarena, Seville

44787

ClinPharm International, Prüfzentrum Bochum, Bochum

45000

Centre Hospitalier Régional - Hôpital Porte Madeleine, Orléans

48013

Servicio de Reumatologia, Hospital de Basurto, Bilbao

50139

Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi, Florence

53100

"Istituto di Reumatologia, Policlinico Le Scotte Università degli Studi di Siena", Siena

56126

Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa, Pisa

60596

ClinPharm Prüfzentrum Frankfurt / aM, Frankfurt

75181

Hôtel Dieu - GHU Ouest, Paris

91054

Medizinische Klinik 3, Universität Erlangen-Nürnberg, Erlangen

01067

ClinPharm International, Prüfzentrum Dresden, Dresden

02826

ClinPharm Prüfzentrum Görlitz, Görlitz

04103

ClinPharm International, Prüfzentrum Leipzig, Leipzig

08208

Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell, Sabadell

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY