Status:
TERMINATED
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
Lead Sponsor:
Warner Chilcott
Conditions:
Neurogenic Detrusor Overactivity
Eligibility:
All Genders
2-15 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
- Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00712322
Start Date
October 7 2008
End Date
May 23 2013
Last Update
June 9 2022
Active Locations (12)
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1
University of California at San Diego
San Diego, California, United States, 92123
2
Children's Hospital, Karp 8210
Boston, Massachusetts, United States, 02115
3
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201-2119
4
Washington University Pediatric Urology
St Louis, Missouri, United States, 63110