Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Warner Chilcott
Age
2–15
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 for inclusion
Female adolescent of child-bearing potential, unless using an acceptable method of contraception
