A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: (4-amino-5-(4-(4-(2,4-dichloro-3-(2,4-dimethyl-8-quinolyloxymethyl)phenylsulfonamido)tetrahydro-2H-4-pyranoylcarbonyl)piperazino)-5-oxopentyl)(trimeth; (4-amino-5-(4-(4-(2,4-dichloro-3-(2,4-dimethyl-8-quinolyloxymethyl)phenylsulfonamido)tetrahydro-2H-4-pyranoylcarbonyl)piperazino)-5-oxopentyl)(trimethyl)ammonium

Criteria

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.