Darifenacin

Generic Name: Darifenacin

Brand Names: Emselex, Enablex

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₃₀N_₂O_₂

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.
...

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

Associated Conditions: Overactive Bladder Syndrome (OABS)

Associated Therapies: -

Clinical Trials

Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1

Phase 4

Completed

Conditions: HTLV-1
Overactive Bladder Syndrome

Interventions: Device: Neuromodulation - Sacral nerve stimulation
Drug: Darifenacin

First Posted Date: 2024-09-27

Last Posted Date: 2024-10-01

Lead Sponsor: Hospital Universitário Professor Edgard Santos

Target Recruit Count: 42

Registration Number: NCT06616675

Locations: 🇧🇷
Ambulatório de HTLV-1 - Com HUPES, Salvador, Ba, Brazil

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

Completed

Conditions: Overactive Bladder (OAB)

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

First Posted Date: 2018-07-27

Last Posted Date: 2024-10-16

Lead Sponsor: Astellas Pharma Singapore Pte. Ltd.

Target Recruit Count: 5589

Registration Number: NCT03602508

Locations: 🇦🇺
Site AU10000, Sydney, Australia
🇰🇷
Site KR82001, Seoul, Korea, Republic of

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

Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women

Phase 3

Completed

Conditions: Overactive Bladder

Interventions: Drug: Darifenacin
Procedure: Physiotherapy

First Posted Date: 2014-05-21

Last Posted Date: 2016-05-02

Lead Sponsor: Universidad de Valparaiso

Target Recruit Count: 80

Registration Number: NCT02143570

Locations: 🇨🇱
Hospital Carlos Van Buren, Valparaiso, Chile

Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.

Phase 1

Conditions: Bioequivalency

Interventions: Drug: Darifenacin

First Posted Date: 2010-10-27

Last Posted Date: 2010-10-27

Lead Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A.

Target Recruit Count: 24

Registration Number: NCT01229280

Locations: 🇺🇾
Center for Clinical Pharmacology Research (CCPR) Bdbeq S.A. Hospital Italiano., Montevideo, Uruguay

Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers.

Phase 1

Conditions: Bioequivalency

Interventions: Drug: Darifenacin

First Posted Date: 2010-10-25

Last Posted Date: 2010-10-25

Lead Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A.

Target Recruit Count: 24

Registration Number: NCT01227811

Locations: 🇺🇾
Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano de Montevideo.., Montevideo, Uruguay

Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain

Not Applicable

Terminated

Conditions: Overactive Bladder
Renal Colic
Pain, Postoperative

Interventions: Drug: Darifenacin

First Posted Date: 2010-08-26

Last Posted Date: 2016-11-21

Lead Sponsor: University of Missouri-Columbia

Target Recruit Count: 3

Registration Number: NCT01189071

Locations: 🇺🇸
University of Missouri Healthcare, Columbia, Missouri, United States

Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

Phase 4

Withdrawn

Conditions: Nocturia

Interventions: Drug: Placebo
Drug: darifenacin

First Posted Date: 2009-11-23

Last Posted Date: 2016-04-13

Lead Sponsor: Cognitive Research Corporation

Registration Number: NCT01018225

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: Drug: Darifenacin

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: Tolterodine
Drug: Placebo
Drug: Darifenacin

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

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