SANCTURA XR SUMMARY
SANCTURA XR is an extended-release formulation of trospium chloride, a quaternary ammonium compound. Trospium chloride is an antispasmodic, antimuscarinic agent.
SANCTURA® XR is 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 XR (Trospium)
Trospium 60 mg once daily (QD) for overactive bladder syndrome: results from a placebo-controlled interventional study. [2008.03]
OBJECTIVES: A once-daily (QD) formulation of trospium chloride has been developed for the management of overactive bladder syndrome (OAB). This randomized controlled trial evaluated the efficacy and tolerability of this new extended-release formulation, trospium chloride 60 mg QD... CONCLUSIONS: Trospium QD represents a convenient, effective, and well-tolerated treatment option for OAB.
Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. [2007.09]
PURPOSE: An extended release formulation of trospium chloride was recently developed for the once daily treatment of overactive bladder. We investigated the safety, efficacy and tolerability of 60 mg trospium chloride once daily... CONCLUSIONS: Trospium once daily provided significant improvements in overactive bladder symptoms (frequency, urgency urinary incontinence and urgency). Efficacy was similar to that seen previously with trospium chloride twice daily, while class effect anticholinergic adverse events occurred at comparatively low levels. Dry mouth was elicited at the lowest reported rate in the oral antimuscarinic drug class.
Trospium chloride in patients with neurogenic detrusor overactivity: is dose titration of benefit to the patients? [2006.12]
OBJECTIVE: To determine whether dose titration based on therapeutic response is superior to standard dosing of oral trospium chloride in patients with neurogenic detrusor overactivity and, moreover, to investigate the possible underlying causes of differences in efficacy at equal doses in some patients... CONCLUSION: Generally, in patients with neurogenic detrusor overactivity daily doses of 45 mg trospium chloride can be considered as being the standard dose, and dose adjustment, e.g. due to increased body weight, might usually not be necessary. However, increased daily doses of up to 135 mg appear to be safe when prescribed in individual patients less responsive to the drug.
Predictive power of an in vitro system to assess drug interactions of an antimuscarinic medication: a comparison of in vitro and in vivo drug-drug interaction studies of trospium chloride with digoxin. [2006.07]
The authors studied a potential drug-drug interaction via findings from in vitro and in vivo studies, to assess whether the in vitro system was predictive of in vivo clinical pharmacokinetic outcomes. An in vitro experiment and a clinical study were performed to assess the potential for interaction...
Multicenter phase III trial studying trospium chloride in patients with overactive bladder. [2006.02]
OBJECTIVES: To study the efficacy and safety of trospium chloride in treating overactive bladder. Trospium chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity and thus has potential therapeutic value in treating patients with overactive bladder... CONCLUSIONS: Trospium chloride had significant and sustained effectiveness beginning at the end of week 1 and continuing through 12 weeks of treatment. Trospium chloride was also safe and generally well tolerated.
Clinical Trials Related to Sanctura XR (Trospium)
Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects [Not yet recruiting]
The purpose of this study is to investigate the safety and tolerability of trospium chloride
(Sanctura XRâ„¢) and metformin hydrochloride (Glucophage) when co-administered.
Trospium Chloride XR in Obese Female Patients With Overactive Bladder [Not yet recruiting]
This study evaluates the effectiveness of trospium XR in obese female patients with
overactive bladder. The study will have a 2-week placebo run-in followed by randomization
to trospium XR or placebo. The study will assess the change from baseline in urinary
frequency, urgency, and incontinence for trospium XR versus a placebo-pill. The study will
be of 14 weeks duration.
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial [Not yet recruiting]
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.
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity [Recruiting]
Phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of
two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with one
standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals with
spinal cord injury.
InSite for Urinary Urge Incontinence [Recruiting]
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