A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: MEN16132 - 0.125 mg; MEN16132 - 0.25 mg; MEN16132 - 0.5 mg; MEN16132 - 0.5 mg; Placebo
Intervention description: Intra-articular administration of two low doses of MEN16132 at 2-week interval.; Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval; Intra-articular injection of two high doses of MEN16132 at 2-week interval; Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval; Intra-articular injection of 2 doses of Placebo control at 2-week interval
Intervention MeSH terms: (4-amino-5-(4-(4-(2,4-dichloro-3-(2,4-dimethyl-8-quinolyloxymethyl)phenylsulfonamido)tetrahydro-2H-4-pyranoylcarbonyl)piperazino)-5-oxopentyl)(trimethyl)ammonium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 423.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Injections, Intra-Articular

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.
    

Eligibility 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.