Abstract | BACKGROUND: A dose-finding study was performed as the first step in the clinical development of the new drug, cizolirtine citrate. OBJECTIVE: 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: 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:
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Authors | Roberto Martínez-García, Montserrat Abadías, Pere Arañó, Lorenzo Perales, José Luis Ruíz, Mariano Sust, Juan Conejero, ESCLIN 006/00 study group |
Journal | European urology
(Eur Urol)
Vol. 56
Issue 1
Pg. 184-90
(Jul 2009)
ISSN: 1873-7560 [Electronic] Switzerland |
PMID | 18485575
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Pyrazoles
- Substance P
- Calcitonin Gene-Related Peptide
- cizolirtine
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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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