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Cizolirtine citrate, an effective treatment for symptomatic patients with urinary incontinence secondary to overactive bladder: a pilot dose-finding study.

AbstractBACKGROUND:
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.
INTERVENTIONS:
Patients received cizolirtine citrate 400 mg bid (C400), cizolirtine citrate 200 mg bid (C200), or placebo.
MEASUREMENTS:
Patients recorded efficacy variables in 7- and 14-d bladder diaries: urinary incontinence episodes, voluntary micturitions, and urgency episodes. The primary efficacy endpoints were changes from baseline to week 12 in average 24-h frequencies of the efficacy variables.
RESULTS AND LIMITATIONS:
Average 24-h frequency of urinary incontinence episodes decreased by a median of 1.14 in C400 versus 0.21 in placebo (p=0.08). Urgency episodes decreased by a median of 3.00 in C400, by 1.29 in C200 and by 0.43 in placebo (p=0.004; C400 vs placebo). Cizolirtine showed a clear improvement regarding the percentage of patients free from urinary incontinence episodes at the end of the study, being 68.75% in C400, 45% in C200, and 30% in placebo (p=0.04; C400 vs placebo). The global efficacy assessment reported by patients showed a clearly favourable opinion ("excellent" or "good") given by 80% of the patients in C400 and 60% in C200 versus 39% in placebo. Patients reporting adverse events (AEs) were 37% in placebo, 68% in C200, and 81% in C400. The majority of AEs had mild to moderate severity and none was serious.
CONCLUSIONS:
The therapeutic potential of cizolirtine citrate 400mg bid in overactive bladder has been evidenced.
AuthorsRoberto Martínez-García, Montserrat Abadías, Pere Arañó, Lorenzo Perales, José Luis Ruíz, Mariano Sust, Juan Conejero, ESCLIN 006/00 study group
JournalEuropean urology (Eur Urol) Vol. 56 Issue 1 Pg. 184-90 (Jul 2009) ISSN: 1873-7560 [Electronic] Switzerland
PMID18485575 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Pyrazoles
  • Substance P
  • Calcitonin Gene-Related Peptide
  • cizolirtine
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Calcitonin Gene-Related Peptide (drug effects, metabolism)
  • Dizziness (chemically induced)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Nausea (chemically induced)
  • Pilot Projects
  • Pyrazoles (administration & dosage)
  • Substance P (drug effects, metabolism)
  • Urinary Bladder, Overactive (complications, drug therapy)
  • Urinary Incontinence (drug therapy, etiology)
  • Urodynamics (drug effects)
  • Vision Disorders (chemically induced)
  • Vomiting (chemically induced)
  • Young Adult

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