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

• Status: Terminated
• Trial end date: 2013-05-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Darifenacin

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.