Aim: To assess the safety, tolerability, pharmacodynamics and pharmacokinetics in healthy subjects of a novel, highly selective, sigma-1 receptor antagonist (S1RA).
Methods: Three randomized, double-blind, placebo-controlled trials evaluated single oral doses (5-500 mg, study 101; 500-800 mg, study 106) and multiple doses (50-400 mg once daily for 8 days, study 102) of S1RA. Safety and tolerability were assessed by adverse event reporting, clinical laboratory, physical examinations, vital signs and electrocardiography, including Holter monitoring.
Background: Antimuscarinic agents currently dominate medical treatment for urinary incontinence secondary to overactive bladder (OAB). Alternatives to improve their risk-benefit ratio are welcomed.
Objective: To demonstrate the efficacy and safety of oral cizolirtine citrate in this indication.
Background: A dose-finding study was performed as the first step in the clinical development of the new drug, cizolirtine citrate.
Objective: To assess the efficacy and safety of cizolirtine citrate in overactive bladder with urinary incontinence.
Design, Setting, And Participants: Seventy-nine outpatients with clinical overactive bladder and/or urodynamic diagnosis of detrusor overactivity were randomized in a multicentre, 12-wk, double-blind, pilot trial.
Background: Renal colic causes excruciating pain that provides a good clinical model of acute pain for the development of new analgesics.
Objective: The purpose of the study was to compare the analgesic efficacy and tolerability of cizolirtine citrate and metamizol sodium in adult acute renal colic.
Methods: This Phase II, randomized, double-blind, clinical pilot study was conducted in the emergency departments of 6 general hospitals in the Czech Republic between October 2000 and February 2001.