A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

NCT ID: NCT01091116

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Detailed Description

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Double dose MEN16132 0.125 mg

Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.

Group Type: EXPERIMENTAL

MEN16132 - 0.125 mg

Intervention Type: DRUG

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

Double dose MEN16132 0.25 mg

Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.

Group Type: EXPERIMENTAL

MEN16132 - 0.25 mg

Intervention Type: DRUG

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

Double dose MEN16132 0.5 mg

Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.

Group Type: EXPERIMENTAL

MEN16132 - 0.5 mg

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

MEN16132 - 0.5 mg

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

MEN16132 - 0.125 mg

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

Intervention Type: DRUG

MEN16132 - 0.25 mg

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

Intervention Type: DRUG

MEN16132 - 0.5 mg

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

Intervention Type: 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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

fasitibant 0.125 mg; fasitibant 0.25 mg; fasitibant 0.5 mg; fasitibant 0.5 mg

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karel Pavelka, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Rheumatology, Charles University Prague

Locations

Centre Hospitalier Régional - Hôpital Porte Madeleine

Orléans, , France

Hôtel Dieu - GHU Ouest

Paris, , France

Department of Rheumatology, Purpan University Hospital

Toulouse, , France

Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan

Bad Doberan, , Germany

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

Berlin, , Germany

Orthopädische Praxis Dr. Wagenitz

Berlin, , Germany

ClinPharm International, Prüfzentrum Bochum

Bochum, , Germany

ClinPharm International, Prüfzentrum Dresden

Dresden, , Germany

Medizinische Klinik 3, Universität Erlangen-Nürnberg

Erlangen, , Germany

ClinPharm Prüfzentrum Frankfurt / aM

Frankfurt, , Germany

ClinPharm Prüfzentrum Görlitz

Görlitz, , Germany

Clinical Research Hamburg

Hamburg, , Germany

Orthopädie Zentrum Altona

Hamburg, , Germany

ClinPharm International, Prüfzentrum Leipzig

Leipzig, , Germany

ClinPharm Prüfzentrum Magdeburg

Magdeburg, , Germany

Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli

Bologna, , Italy

Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

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

Pisa, , Italy

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

Siena, , Italy

Servicio de Reumatologia, Hospital de Basurto

Bilbao, , Spain

Servicio de Reumatologia, Hospital Universitario La Paz

Madrid, , Spain

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

Sabadell, , Spain

Servicio de Reumatologia, Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

France; Germany; Italy; Spain

Other Identifiers

2009-014918-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BKOS-02

Identifier Type: -

Identifier Source: org_study_id