PMID- 18485575
OWN - NLM
STAT- MEDLINE
DCOM- 20100402
LR  - 20181201
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 56
IP  - 1
DP  - 2009 Jul
TI  - Cizolirtine citrate, an effective treatment for symptomatic patients with urinary 
      incontinence secondary to overactive bladder: a pilot dose-finding study.
PG  - 184-90
LID - 10.1016/j.eururo.2008.04.027 [doi]
AB  - 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. 
      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.
FAU - Martinez-Garcia, Roberto
AU  - Martinez-Garcia R
AD  - Hospital Clinico, Universidad de Valencia, Spain.
FAU - Abadias, Montserrat
AU  - Abadias M
FAU - Arano, Pere
AU  - Arano P
FAU - Perales, Lorenzo
AU  - Perales L
FAU - Ruiz, Jose Luis
AU  - Ruiz JL
FAU - Sust, Mariano
AU  - Sust M
FAU - Conejero, Juan
AU  - Conejero J
CN  - ESCLIN 006/00 study group
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080418
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Pyrazoles)
RN  - 33507-63-0 (Substance P)
RN  - JHB2QIZ69Z (Calcitonin Gene-Related Peptide)
RN  - SMP167WV5D (cizolirtine)
SB  - IM
CIN - Eur Urol. 2009 Jul;56(1):191. PMID: 18485571
CIN - Eur Urol. 2009 Jul;56(1):191-2. PMID: 18485574
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Calcitonin Gene-Related Peptide/drug effects/metabolism
MH  - Dizziness/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Pilot Projects
MH  - Pyrazoles/*administration & dosage
MH  - Substance P/drug effects/metabolism
MH  - Urinary Bladder, Overactive/complications/*drug therapy
MH  - Urinary Incontinence/*drug therapy/etiology
MH  - Urodynamics/drug effects
MH  - Vision Disorders/chemically induced
MH  - Vomiting/chemically induced
MH  - Young Adult
FIR - Martinez-Agullo, E
IR  - Martinez-Agullo E
FIR - Arlandis, S
IR  - Arlandis S
FIR - Leal, A
IR  - Leal A
FIR - Garcia, M
IR  - Garcia M
FIR - Blasco, P
IR  - Blasco P
FIR - Sanchez Rodriguez-Losada, J
IR  - Sanchez Rodriguez-Losada J
FIR - Gelabert, A
IR  - Gelabert A
FIR - Bielsa, O
IR  - Bielsa O
EDAT- 2008/05/20 09:00
MHDA- 2010/04/03 06:00
CRDT- 2008/05/20 09:00
PHST- 2008/01/17 00:00 [received]
PHST- 2008/04/10 00:00 [accepted]
PHST- 2008/05/20 09:00 [pubmed]
PHST- 2010/04/03 06:00 [medline]
PHST- 2008/05/20 09:00 [entrez]
AID - S0302-2838(08)00473-9 [pii]
AID - 10.1016/j.eururo.2008.04.027 [doi]
PST - ppublish
SO  - Eur Urol. 2009 Jul;56(1):184-90. doi: 10.1016/j.eururo.2008.04.027. Epub 2008 Apr 
      18.