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

Condition(s) targeted: Neurogenic Detrusor Overactivity

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Warner Chilcott

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

Overall contact:
Michelle Brown, Phone: 973-442-3247, Email: michelle.brown@wcrx.com

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.

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.

Criteria:

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

tract

- 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

structures

- 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

contraception

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

inclusion/exclusion criteria may apply.

Michelle Brown, Phone: 973-442-3247, Email: michelle.brown@wcrx.com

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

Fundación Valle de Lili, Cali, Colombia; Recruiting

Hospital Pablo Tobon Uribe, Medellín, Colombia; Recruiting

Federal Healthcare Institution "Scientific Research Institution of Urology", Moscow, Russian Federation; Withdrawn

State Institution "Scientific Center for Child Health of Russian Academy", Moscow, Russian Federation; Withdrawn

Steve Biko Academic Hospital, Pretoria, South Africa; Withdrawn

Mayo Clinic, Roodepoort, South Africa; Withdrawn

Hacettepe University Medical Faculty, Ankara, Turkey; Withdrawn

Ankara University Medical Faculty Ibn-i Sina, Ankara, Turkey; Withdrawn

Akdeniz University Medical Faculty, Antalya, Turkey; Withdrawn

Marmara University Medical Faculty, Istanbul, Turkey; Withdrawn

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

Miami Children's Hospital, Miami, Florida 33155, United States; Recruiting

St Joseph's Hospital Comprehensive Research Institute, Tampa, Florida 33614, United States; Withdrawn

Southern Illinois University SDM, Springfield, Illinois 62794, United States; Withdrawn

Gulf Coast Research LLC, Lafayette, Louisiana 70508, United States; Withdrawn

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

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

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

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

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

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

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

Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Withdrawn

University of Oklahoma Health Science Center, Oklahoma City, Oklahoma 73104, United States; Withdrawn

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

University Urological Associates Inc, Providence, Rhode Island 02905, United States; Withdrawn

Children's Hospital & Regional Medical Center, Seattle, Washington 98101, United States; Withdrawn

Starting date: October 2008
Last updated: January 17, 2013