2 Week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (6 - 15 Yrs) With Neurogenic Detrusor Overactivity


Tracking Information

Start Date  ICMJEOctober 2008
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: July 3, 2008)		Change from baseline to day 14 in the urodynamic parameter "volume at first contraction", comparing multiple doses of darifenacin liquid oral suspension [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00712322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 3, 2008)		Comparing effect of multiple doses of darifenacin liquid oral suspension, on: • Urodynamic, pharmacokinetic, efficacy parameters • Safety, tolerability [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJE2 Week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (6 - 15 Yrs) With Neurogenic Detrusor Overactivity
Official Title  ICMJEA 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 a Darifenacin Liquid Oral Suspension Given b.i.d. in Children, Ages 6 - 15 Years, With Neurogenic Detrusor Overactivity
Brief Summary

This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 6-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Condition  ICMJENeurogenic Detrusor Overactivity
Intervention  ICMJE
  • Drug: Darifenacin
    (0.030 mg/kg/day)
    Other Name: Enablex®, Emselex®
  • Drug: Darifenacin
    (0.0625 mg/kg/day)
    Other Name: Enablex®, Emselex®
  • Drug: Darifenacin
    (0.125 mg/kg/day)
    Other Name: Enablex®, Emselex®
  • Drug: Darifenacin
    (0.250 mg/kg/day)
    Other Name: Enablex®, Emselex®
Study Arms / Comparison Groups
  • Cohort 1: Experimental
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.030 mg/kg/day).
    Intervention: Drug: Darifenacin
  • Cohort 2: Experimental
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.0625 mg/kg/day).
    Intervention: Drug: Darifenacin
  • Cohort 3: Experimental
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.125 mg/kg/day).
    Intervention: Drug: Darifenacin
  • Cohort 4: Experimental
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.250 mg/kg/day).
    Intervention: Drug: Darifenacin

Recruitment Information

Estimated Enrollment  ICMJE60
Estimated Completion DateJune 2009
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients ages 6-15 years
  • Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele, 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.
GenderBoth
Ages6 Years to 15 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis862-778-8300
Location Countries  ICMJEUnited States,   Colombia,   Russian Federation,   South Africa,   Turkey

Administrative Information

NCT ID  ICMJENCT00712322
Responsible PartyExternal Affairs, Novartis
Study ID Numbers  ICMJECDAR328B2201
Study Sponsor  ICMJENovartis
Collaborators  ICMJEProcter and Gamble
Investigators  ICMJE
Study Chair:NovartisNovartis Pharmaceuticals
Information Provided ByNovartis