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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 has been terminated.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00712322
First received: July 3, 2008
Last updated: July 14, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 9
Study Start Date: October 2008
Study Completion Date: May 2013
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712322

Locations
United States, California
University of California at San Diego
San Diego, California, United States, 92123
United States, Massachusetts
Children's Hospital, Karp 8210
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201-2119
United States, Missouri
Washington University Pediatric Urology
Saint Louis, Missouri, United States, 63110
United States, New York
Pediatric Urology Associates, PC
Lake Success, New York, United States, 11042
Pediatric Urology Associates PC
Tarrytown, New York, United States, 10591
United States, Ohio
Pediatric & Adolescent Urology, Inc Akron Children's Hospital
Akron, Ohio, United States, 44302
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Argentina
Warner Chilcott Investigational Study Site
Buenos Aires, Argentina, C1181ACH
Colombia
Fundacion Hospital Infantil, Universitario De San Jose
Bogota, Colombia
Fundación Valle de Lili
Cali, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
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: July 14, 2014
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
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014