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 - Full Text View

Sponsor:	Warner Chilcott
Information provided by (Responsible Party):	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00712322

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 II

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:

Genetics Home Reference related topics: spina bifida

Drug Information available for: Darifenacin Darifenacin hydrobromide

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:	June 2012
Estimated Primary Completion Date:	June 2012 (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: Terry White

973-442-3200 ext 3888

theresa.white@wcrx.com

Show 23 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:	October 18, 2011
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 February 09, 2012