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 - Full Text View

Sponsors and Collaborators:	Novartis Procter and Gamble
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00712322

Purpose

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.

Condition	Intervention	Phase
Neurogenic Detrusor Overactivity	Drug: Darifenacin	Phase II

Drug Information available for: Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
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 a Darifenacin Liquid Oral Suspension Given b.i.d. in Children, Ages 6 - 15 Years, With Neurogenic Detrusor Overactivity

Further study details as provided by Novartis:

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 2009

Arms	Assigned Interventions
Cohort 1: Experimental Estimated pediatric study doses of darifenacin liquid oral suspension: (0.030 mg/kg/day).	Drug: Darifenacin (0.030 mg/kg/day)
Cohort 2: Experimental Estimated pediatric study doses of darifenacin liquid oral suspension: (0.0625 mg/kg/day).	Drug: Darifenacin (0.0625 mg/kg/day)
Cohort 3: Experimental Estimated pediatric study doses of darifenacin liquid oral suspension: (0.125 mg/kg/day).	Drug: Darifenacin (0.125 mg/kg/day)
Cohort 4: Experimental Estimated pediatric study doses of darifenacin liquid oral suspension: (0.250 mg/kg/day).	Drug: Darifenacin (0.250 mg/kg/day)

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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

Contacts

Contact: Novartis

862-778-8300

Locations

United States, Florida
St Joseph's Hospital Comprehensive Research Institute	Recruiting
Tampa, Florida, United States, 33614
United States, Illinois
Southern Illinois University SDM	Withdrawn
Springfield, Illinois, United States, 62794
United States, Louisiana
Gulf Coast Research LLC	Recruiting
Lafayette, Louisiana, United States, 70508
United States, Massachusetts
Children's Hospital, Karp 8210	Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University Pediatric Urology	Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Pediatric Urology Associates PC	Recruiting
Tarrytown, New York, United States, 10591
Pediatric Urology Associates, PC	Recruiting
Lake Success, New York, United States, 11042
United States, Ohio
Nationwide Children's Hospital	Withdrawn
Columbus, Ohio, United States, 43205
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Pediatric & Adolescent Urology, Inc Akron Children's Hospital	Not yet recruiting
Akron, Ohio, United States, 44302
United States, Oklahoma
University of Oklahoma Health Science Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
University Urological Associates Inc	Recruiting
Providence, Rhode Island, United States, 02905
United States, Washington
Children's Hospital & Regional Medical Center	Not yet recruiting
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Novartis

Procter and Gamble

Investigators

Study Chair:

Novartis

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328B2201
Study First Received:	July 3, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00712322
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Pediatric, Children, Urodynamics, Oral suspension, Overactive bladder, Dose-finding, Neurogenic Detrusor Overactivity, Meningomyelocele, Spinal cord injury

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Meningomyelocele

Spinal Cord Injuries
Darifenacin
Meningocele

Additional relevant MeSH terms:

Muscarinic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009