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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.
University of California at San Diego
San Diego, California, United States
Children's Hospital, Karp 8210
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Change From Baseline in Mean Maximum Bladder Capacity (MBC)
MBC was defined as the volume of urine at which significant urinary leakage (i.e. leakage that prevents further volume increase) or significant discomfort/pain occurs, or a detrusor pressure at 40 centimeter (cm) H2O was reached.
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at First Contraction
Average volume of urine collected by catheterization at first contraction.
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Detrusor Pressure at First Contraction
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at First Detectable Leakage
Average volume of urine collected by catheterization at first detectable leakage.
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Catheterization Volume
Average volume of urine was collected by catheterization and was recorded in a bladder diary. Bladder volume was assessed by urodynamics. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement.
Time frame: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
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Washington University Pediatric Urology
St Louis, Missouri, United States
Pediatric Urology Associates, PC
Lake Success, New York, United States
Pediatric Urology Associates PC
Tarrytown, New York, United States
Pediatric & Adolescent Urology, Inc Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Fundacion Hospital Infantil, Universitario De San Jose
Bogotá, Colombia
...and 2 more locations
Change From Baseline in Total Pad Weight In-between Catheterizations
Urodynamic test was used to assess the total pad weight in-between catheterizations. The change in total pad weight in-between catheterizations was recorded in the bladder diary. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement.
Time frame: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Change From Baseline in Mean Catheterization Volume at First Awakening
The change in urine volume at first awakening catherization was recorded by the participant in a bladder diary. Bladder volume was assessed by urodynamics. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement.
Time frame: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14