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
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Intervention: Darifenacin
Intervention description: Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.
Intervention MeSH terms: Darifenacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Pediatric, Children, Urodynamics, Oral Suspension, Overactive bladder, Dose-finding, Neurogenic Detrusor Overactivity, Meningomyelocele, Spinal cord injury

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants 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

          -  Participants 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. Participants 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

          -  Participants with any physical and cognitive impairment or any other condition which
             in the opinion of the investigator makes the participants 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.