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Darifenacin

Generic Name
Darifenacin
Brand Names
Emselex, Enablex
Drug Type
Small Molecule
Chemical Formula
C28H30N2O2
CAS Number
133099-04-4
Unique Ingredient Identifier
APG9819VLM
Background

Darifenacin (Enablex®, Novartis) is a medication used to treat urinary incontinence.

Darifenacin blocks M3 muscarinic acetylcholine receptors, which mediate bladder muscle contractions. This block reduces the urgency to urinate and so it should not be used in people with urinary retention.

It is unknown if M3 receptor selectivity is clinically advantageous in overactive bladder syndrome treatments.

Indication

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Associated Conditions
Overactive Bladder Syndrome (OABS)
Clinical Trials
Related News

Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

Phase 2
Terminated
Conditions
Overactive Detrusor
Multiple Sclerosis
Interventions
First Posted Date
2009-02-18
Last Posted Date
2014-12-02
Lead Sponsor
Bayer
Target Recruit Count
7
Registration Number
NCT00845338

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
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

Post Marketing Surveillance Study on Emselex After Launch in Germany

Completed
Conditions
Overactive Bladder
Interventions
First Posted Date
2008-11-06
Last Posted Date
2010-04-30
Lead Sponsor
Bayer
Target Recruit Count
5821
Registration Number
NCT00786448

A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity

Phase 2
Terminated
Conditions
Neurogenic Detrusor Overactivity
Interventions
First Posted Date
2008-07-09
Last Posted Date
2022-06-09
Lead Sponsor
Warner Chilcott
Target Recruit Count
35
Registration Number
NCT00712322
Locations
🇺🇸

Children's Hospital of Michigan, Detroit, Michigan, United States

🇺🇸

Pediatric Urology Associates, PC, Lake Success, New York, United States

🇺🇸

Washington University Pediatric Urology, Saint Louis, Missouri, United States

and more 9 locations

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2008-06-23
Last Posted Date
2012-08-02
Lead Sponsor
Novartis
Target Recruit Count
117
Registration Number
NCT00703703
Locations
🇺🇸

Investigative Site, Morgantown, West Virginia, United States

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

Phase 4
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2006-12-20
Last Posted Date
2008-01-15
Lead Sponsor
Novartis
Target Recruit Count
162
Registration Number
NCT00413790
Locations
🇺🇸

Investigative Site, Dallas, Texas, United States

Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2006-12-19
Last Posted Date
2016-04-12
Lead Sponsor
Novartis
Target Recruit Count
28
Registration Number
NCT00413426
Locations
🇮🇳

Novartis Investigative Site, Mumbai, India

Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

Phase 4
Completed
Conditions
Overactive Bladder (OAB)
Interventions
First Posted Date
2006-08-18
Last Posted Date
2008-01-15
Lead Sponsor
Novartis
Target Recruit Count
500
Registration Number
NCT00366002
Locations
🇺🇸

Investigative Site, Milwaukee, Wisconsin, United States

Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Phase 4
Completed
Conditions
Overactive Bladder
Interventions
Drug: Placebo
First Posted Date
2005-09-15
Last Posted Date
2017-05-18
Lead Sponsor
Novartis
Target Recruit Count
400
Registration Number
NCT00171184
Locations
🇺🇸

Scott Department of Urology Baylor College of Medicine, Houston, Texas, United States

A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Phase 3
Completed
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2005-09-15
Last Posted Date
2008-01-17
Lead Sponsor
Novartis
Target Recruit Count
718
Registration Number
NCT00170755
Locations
🇺🇸

Novartis, East Hanover, New Jersey, United States

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