Trospium

Generic Name: Trospium

Brand Names: Trosec

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₃₀NO_₃

CAS Number: 47608-32-2

Unique Ingredient Identifier: T4Y8ORK057

Background: Trospium is an antispasmodic agent used to treat the symptoms of overactive bladder, a condition that causes the bladder muscles to contract uncontrollably. An overactive bladder leads to an increased urge to urinate, frequent urination, and sometimes, loss of control over urination. Trospium is manufactured by Indevus Pharmaceutical Inc. and was granted FDA approval in 2007.

Indication: For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, detrusor instability and frequency of micturition.

Associated Conditions: Overactive Bladder Syndrome (OABS)

Clinical Trials

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Completed

Conditions: Overactive Bladder (OAB)

Interventions: Device: solifenacin
Drug: mirabegron
Drug: darifenacin
Drug: imidafenacin
Drug: tolterodine
Drug: oxybutynin
Drug: trospium
Drug: fesoterodine
Device: propiverine

First Posted Date: 2018-06-28

Last Posted Date: 2020-04-22

Lead Sponsor: Astellas Pharma Singapore Pte. Ltd.

Target Recruit Count: 805

Registration Number: NCT03572231

Locations: 🇰🇷
Site KR410008, Daejeon, Korea, Republic of
🇰🇷
Site KR410009, Incheon, Korea, Republic of
🇰🇷
Site KR410005, Kangam, Korea, Republic of

and more 12 locations

Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

Phase 1

Completed

Conditions: Schizophrenia

Interventions: Drug: xanomeline tartrate
Drug: Trospium chloride

First Posted Date: 2016-07-13

Last Posted Date: 2017-04-19

Lead Sponsor: Karuna Therapeutics

Target Recruit Count: 70

Registration Number: NCT02831231

Locations: 🇺🇸
Medpace, Cincinnati, Ohio, United States

The Effect of Anticholinergics on Cognitive Function in the Elderly

Phase 4

Completed

Conditions: Cognitive Function
Mental Competency
Urinary Bladder, Overactive

Interventions: Drug: Trospium Chloride
Drug: Placebo

First Posted Date: 2013-08-14

Last Posted Date: 2017-03-22

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 59

Registration Number: NCT01922115

Locations: 🇺🇸
Unc Chapel Hill Urogynecology A2 Clinic, Chapel Hill, North Carolina, United States

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial

Phase 4

Completed

Conditions: Overactive Bladder

Interventions: Drug: trospium chloride
Drug: oxybutynin IR
Drug: oxybutynin IR placebo

First Posted Date: 2010-08-10

Last Posted Date: 2016-02-26

Lead Sponsor: Allergan

Target Recruit Count: 20

Registration Number: NCT01178827

Anticholinergic vs. Botox Comparison Study

Phase 3

Completed

Conditions: Urge Urinary Incontinence
Overactive Bladder

Interventions: Drug: Solifenacin 5mg
Drug: Botulinum toxin A (Botox A®)
Drug: Solifenacin 10mg
Drug: Trospium chloride

First Posted Date: 2010-07-21

Last Posted Date: 2018-05-02

Lead Sponsor: NICHD Pelvic Floor Disorders Network

Target Recruit Count: 249

Registration Number: NCT01166438

Locations: 🇺🇸
Loyola University Medical Center, Maywood, Illinois, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Magee-Women's Hospital, Pittsburgh, Pennsylvania, United States

and more 8 locations

Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

Phase 4

Completed

Conditions: Overactive Bladder

Interventions: Drug: trospium chloride
Drug: placebo

First Posted Date: 2010-03-19

Last Posted Date: 2013-09-26

Lead Sponsor: Allergan

Target Recruit Count: 322

Registration Number: NCT01089751

Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Trospium Chloride (Sanctura XR®)
Drug: Metformin hydrochloride (Glucophage®)

First Posted Date: 2009-09-30

Last Posted Date: 2011-12-19

Lead Sponsor: Allergan

Target Recruit Count: 44

Registration Number: NCT00986401

Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Phase 4

Completed

Conditions: Obesity
Overactive Bladder
Incontinence

Interventions: Drug: Trospium Chloride, Extended Release (XR)
Other: placebo

First Posted Date: 2009-07-02

Last Posted Date: 2013-01-21

Lead Sponsor: Allergan

Target Recruit Count: 127

Registration Number: NCT00932022

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Phase 4

Completed

Conditions: Pharmacokinetics
Elderly
Overactive Bladder

Interventions: Drug: Trospium Chloride

First Posted Date: 2009-03-18

Last Posted Date: 2016-02-26

Lead Sponsor: Allergan

Target Recruit Count: 12

Registration Number: NCT00863551

Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

Phase 4

Completed

Conditions: Spinal Cord Injury
Neurogenic Detrusor Overactivity

Interventions: Drug: Oxybutynin Cl
Drug: Trospium Cl
Drug: Darifenacin Hydrogen Bromide (HBr)

First Posted Date: 2008-12-02

Last Posted Date: 2013-04-08

Lead Sponsor: Toronto Rehabilitation Institute

Target Recruit Count: 23

Registration Number: NCT00800462

Locations: 🇨🇦
University of Manitoba, Health Sciences Centre, Winnipeg, Manitoba, Canada
🇨🇦
Toronto Rehabilitation Institute, Lyndhurst Centre, Toronto, Ontario, Canada

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