SANCTURA SUMMARY
SANCTURA XR® is an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2. 1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α).
SANCTURA XR® is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
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NEWS HIGHLIGHTS
Published Studies Related to Sanctura (Trospium)
Once-daily trospium chloride 60 mg extended release in subjects with overactive bladder syndrome who use multiple concomitant medications: Post hoc analysis of pooled data from two randomized, placebo-controlled trials. [2011.02.01] BACKGROUND: Overactive bladder syndrome (OAB) is associated with various co-morbidities; treatment of these frequently results in multiple medication use (MMU) and the potential for drug-drug interactions, which may lead to adverse events and altered efficacy... The data support the conclusion that trospium chloride XR is safe and effective in patients with OAB taking multiple concomitant medications.
Trospium chloride once-daily extended release is efficacious and tolerated in elderly subjects (aged >/= 75 years) with overactive bladder syndrome. [2011.02] CONCLUSIONS: * Once-daily trospium chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged >/= 75 years with OAB. * For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year. (c) 2010 THE AUTHORS. JOURNAL COMPILATION (c) 2010 BJU INTERNATIONAL.
Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder. [2011.01] OBJECTIVES: This study used pooled data from 2 large, phase III, double-blind, randomized, placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release (XR) in men with overactive bladder (OAB)... CONCLUSIONS: Trospium XR is safe and effective in men with OAB. The risk of urinary retention is low and may be further decreased by careful patient selection. Copyright A(c) 2011 Elsevier Inc. All rights reserved.
Once-daily trospium chloride 60 mg extended-release provides effective, long-term
relief of overactive bladder syndrome symptoms. [2011] tolerability of trospium XR... CONCLUSIONS: Long-term treatment of OAB with once-daily trospium 60 mg XR is
Comparison of intravaginal electrical stimulation and trospium hydrochloride in women with overactive bladder syndrome: a randomized controlled study. [2010.04] OBJECTIVE: To compare the effects of trospium hydrochloride and electrical stimulation on urodynamic parameters, bladder diary, quality of life and psychological symptoms in female patients with overactive bladder syndrome... CONCLUSION: No difference was detected between trospium hydrochloride and intravaginal electrical stimulation in the treatment of female overactive bladder syndrome. Discontinuation of both treatments caused deterioration in most of the objective and subjective symptoms of overactive bladder syndrome.
Clinical Trials Related to Sanctura (Trospium)
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial [Completed]
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®)
and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with
overactive bladder and age associated memory impairment.
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily [Completed]
This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily
in reducing urgency, urinary frequency and urinary urge incontinence in female patients with
incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial [Completed]
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at
plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium
levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured.
Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable
change index to assess if any study subject shows evidence of a clinically and statistically
significant change in memory.
Trospium Chloride XR in Obese Female Patients With Overactive Bladder [Completed]
This study evaluated the effectiveness of trospium chloride extended release (XR) in obese
female patients with overactive bladder (OAB). Patients received either placebo and
trospium chloride XR or placebo only. The study assessed the change from baseline in
urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill.
The study was 14 weeks in duration.
The Effect of Anticholinergics on Cognitive Function in the Elderly [Completed]
Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of
this medication is cognitive dysfunction. OAB is more prevalent in the elderly population -
a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to
evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
Subjects will be randomized to: 1) trospium chloride or 2) placebo. There are three aims: 1)
To evaluate changes in cognitive function in elderly women taking trospium versus placebo,
using validated cognitive assessment tests. 2) To develop a useful battery of cognitive
screening tests for monitoring the cognitive safety of OAB management. 3) To understand how
the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The
investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive
assessments will be performed at baseline and Week 1 and 4 after drug initiation using
paper-based validated questionnaires. OAB improvement will be assessed with validated
questionnaires.
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