• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Sanctura (trospium chloride)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Sanctura (trospium chloride)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Sanctura oral tablets contain trospium, an antimuscarinic antispasmodic agent. Antimuscarinic agents act as parasympathetolytics in muscular tissues, and has been shown to reduce the tonus (elastic tension) of smooth muscles of the bladder.

    It is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

    Sanctura is administered via oral tablets of 20 mg twice daily, with a possible reduction in dosage, to 20 mg once daily, in the elderly and in subjects with renal impairment. Dosing should occur at least 1 hour prior to meal times.

    Clinical Results

    FDA approval of Sanctura was based upon two 12 week, double-blind, placebo controlled studies. The first study enrolled a total of 523 subjects with urge or mixed (predominantly urge) incontinence, with >70 micturitions and >7 urge incontinence episodes per week. Subjects received either 20 mg. Sanctura (n=262) or placebo (n=261) twice daily for 12 weeks. Subjects receiving Sanctura were shown to have significantly fewer micturitions per day (p < 0.001), significantly fewer urge incontinence episodes per week (p = 0.012), and significantly greater void volume per micturition (p < 0.001). The second trial, which enrolled 658 subjects (329 Sanctura, 329 placebo), consistently confirmed the results of the first.

    Side Effects

    Adverse events associated with the use of Sanctura may include, but are not limited to, the following:

    • Dry mouth
    • Constipation
    • Dyspepsia
    • Headache

    In addition, angioneurotic edema was observed in one subject during clinical investigation; it is has not been determined if this reaction represents a clinically relevant event.

    Mechanism of Action

    Trospium chloride acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. It has been shown to have negligible affinity for nicotinic acteylcholine receptors at therapeutic doses, and to not easily cross the blood-brain barrier, yielding a localized, potent anticholinergic for peripheral targets. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

    Literature References

    Zinner N, Gittelman M, Harris R, Susset J, Kanelos A, Auerbach S; Trospium Study Group. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. Journal of Urology. 2004 Jun;171(6 Pt 1):2311-5, quiz 2435.

    Guay DR. Clinical pharmacokinetics of drugs used to treat urge incontinence. Clinical Pharmacokinetics. 2003;42(14):1243-85. Review.

    Hay-Smith J, Herbison P, Ellis G, Moore K. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database of Systematic Reviews 2002;(3):CD003781. Review.

    Additional Information

    For additional information regarding Sanctura or overactive bladder, please contact the Sanctura Web Site

    Approval Date: 2004-05-01
    Company Name: Indevus Pharmaceuticals
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing