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

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neurogenic Detrusor Overactivity

Intervention: Darifenacin (Drug); Darifenacin (Drug); Darifenacin (Drug); Darifenacin (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Herman Ellman, MD, Study Director, Affiliation: Warner Chilcott (US) LLC


This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

Clinical Details

Official title: A 14-day, Open-label, Multicenter, Dose-escalating, Sequential Cohort Study to Evaluate Pharmacodynamics (Urodynamics) and Pharmacokinetics, Clinical Efficacy, Tolerability and Safety, Following Multiple Doses (mg/kg/Day) of Darifenacin Liquid Oral Suspension Given b.i.d. (Twice Daily) in Children, Ages 2 - 15 Years, With Neurogenic Detrusor Overactivity

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline to day 14 in the urodynamic parameter "volume at first contraction", comparing multiple doses of darifenacin liquid oral suspension

Secondary outcome: Comparing effect of multiple doses of darifenacin liquid oral suspension, on: • Urodynamic, pharmacokinetic, efficacy parameters • Safety, tolerability


Minimum age: 2 Years. Maximum age: 15 Years. Gender(s): Both.


Inclusion Criteria:

- Male and female patients ages 2-15 years

- Documented detrusor overactivity associated with a known neurological condition such

as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline

- Using clean intermittent catheterization (CIC) on a regular basis

- Participating in a bowel program on a regular basis

- Able to swallow the study medication in accordance to the protocol

- Patients and/or parent/guardian able to complete the bladder diary and follow the

study procedures Exclusion Criteria:

- Treatment with drugs known to significantly affect the urinary bladder and urinary

bladder outlet function

- Fecal impaction. Patients may be included, once this condition has resolved

- Clinically significant anatomical abnormalities or acquired disorders of the urinary


- Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet

- Symptomatic urinary tract infection unresolved at time of urodynamic study and/or

completion of bladder diary.

- Diabetes insipidus

- Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and

at any time during the study

- Concomitant diseases, in which the use of darifenacin is contraindicated

- History of hypersensitivity to darifenacin or to drugs with similar chemical


- Patients with any physical and cognitive impairment or any other condition which in

the opinion of the investigator makes the patient unsuitable for inclusion

- Female adolescent of child-bearing potential, unless using an acceptable method of


- Pregnant or nursing (lactating) female adolescents Other protocol-defined

inclusion/exclusion criteria may apply.

Locations and Contacts

Warner Chilcott Investigational Study Site, Buenos Aires C1181ACH, Argentina

Fundacion Hospital Infantil, Universitario De San Jose, Bogota, Colombia

Fundación Valle de Lili, Cali, Colombia

Hospital Pablo Tobon Uribe, Medellín, Colombia

University of California at San Diego, San Diego, California 92123, United States

Children's Hospital, Karp 8210, Boston, Massachusetts 02115, United States

Children's Hospital of Michigan, Detroit, Michigan 48201-2119, United States

Washington University Pediatric Urology, Saint Louis, Missouri 63110, United States

Pediatric Urology Associates, PC, Lake Success, New York 11042, United States

Pediatric Urology Associates PC, Tarrytown, New York 10591, United States

Pediatric & Adolescent Urology, Inc Akron Children's Hospital, Akron, Ohio 44302, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States

Oregon Health & Science University, Portland, Oregon 97239, United States

Additional Information

Starting date: October 2008
Last updated: January 22, 2015

Page last updated: August 23, 2015

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