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
Tracking Information
Start Date ICMJE | October 2008 |
---|---|
Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: July 3, 2008) | 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 ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00712322 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 3, 2008) | 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 ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | 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 |
---|---|
Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Condition ICMJE | Neurogenic Detrusor Overactivity |
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 60 | ||||
---|---|---|---|---|---|
Estimated Completion Date | June 2009 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 6 Years to 15 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | United States, Colombia, Russian Federation, South Africa, Turkey |
Administrative Information
NCT ID ICMJE | NCT00712322 | ||||
---|---|---|---|---|---|
Responsible Party | External Affairs, Novartis | ||||
Study ID Numbers ICMJE | CDAR328B2201 | ||||
Study Sponsor ICMJE | Novartis | ||||
Collaborators ICMJE | Procter and Gamble | ||||
Investigators ICMJE |
| ||||
Information Provided By | Novartis |
Source: http://clinicaltrials.gov/