A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenaci… (NCT00712322) | Clinical Trial Compass
TerminatedPhase 2
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
Stopped: Due to extremely difficult enrollment.
United States35 participantsStarted 2008-10-07
Plain-language 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.
Who can participate
Age range2 Years – 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female participants 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
* Participants 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. Participants 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
* Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable fo…
What they're measuring
1
Change From Baseline in Mean Maximum Bladder Capacity (MBC)