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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

This study is currently recruiting participants.
Verified January 2013 by Warner Chilcott
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00712322
First received: July 3, 2008
Last updated: January 17, 2013
Last verified: January 2013
History of Changes

July 3, 2008
January 17, 2013
October 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00712322 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neurogenic Detrusor Overactivity
  • 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®
  • Experimental: Cohort 1
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.030 mg/kg/day).
    Intervention: Drug: Darifenacin
  • Experimental: Cohort 2
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.0625 mg/kg/day).
    Intervention: Drug: Darifenacin
  • Experimental: Cohort 3
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.125 mg/kg/day).
    Intervention: Drug: Darifenacin
  • Experimental: Cohort 4
    Estimated pediatric study doses of darifenacin liquid oral suspension: (0.250 mg/kg/day).
    Intervention: Drug: Darifenacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
2 Years to 15 Years
No
Contact: Michelle Brown 973-442-3247 michelle.brown@wcrx.com
United States,   Colombia,   Russian Federation,   South Africa,   Turkey
 
NCT00712322
CDAR328B2201
Yes
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Herman Ellman, MD Warner Chilcott (US) LLC
Warner Chilcott
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP