Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm,
dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy,
safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of
fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.
Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a
clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a
total of 4 treatment arms. Each arm includes a single intra-articular injection of one of
three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation
ratio will be 1:1:1:1.
The primary efficacy variable will be the change of the Western Ontario and McMaster
Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline
up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and
clinical laboratory tests; local tolerability at the injection site will also be assessed. In
addition, the population pharmacokinetics and the exposure-response relationship will be
evaluated.
The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7
planned visits at site, including screening, randomisation, 4 follow-up visits and the End of
study visit.