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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
  Purpose

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.


Condition Intervention Phase
Neurogenic Detrusor Overactivity
 Drug: Darifenacin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Estimated pediatric study doses of darifenacin liquid oral suspension: (0.030 mg/kg/day).
 Drug: Darifenacin
(0.030 mg/kg/day)
Other Name: Enablex®, Emselex®
Experimental: Cohort 2
Estimated pediatric study doses of darifenacin liquid oral suspension: (0.0625 mg/kg/day).
 Drug: Darifenacin
(0.0625 mg/kg/day)
Other Name: Enablex®, Emselex®
Experimental: Cohort 3
Estimated pediatric study doses of darifenacin liquid oral suspension: (0.125 mg/kg/day).
 Drug: Darifenacin
(0.125 mg/kg/day)
Other Name: Enablex®, Emselex®
Experimental: Cohort 4
Estimated pediatric study doses of darifenacin liquid oral suspension: (0.250 mg/kg/day).
 Drug: Darifenacin
(0.250 mg/kg/day)
Other Name: Enablex®, Emselex®

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712322

Contacts
Contact: Michelle Brown 973-442-3247 michelle.brown@wcrx.com

  Show 28 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott (US) LLC
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00712322     History of Changes
Other Study ID Numbers: CDAR328B2201
Study First Received: July 3, 2008
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Pediatric, Children, Urodynamics, Oral Suspension, Overactive bladder, Dose-finding, Neurogenic Detrusor Overactivity, Meningomyelocele, Spinal cord injury

Additional relevant MeSH terms:
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013