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 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 BID in Children, Ages 2 - 15 Years, With Neurogenic Detrusor Overactivity
Sponsor: Warner Chilcott
Terminated
Due to extremely difficult enrollment.
Listed as NCT00712322, this PHASE2 trial focuses on Neurogenic Detrusor Overactivity and remains terminated or withdrawn. Sponsored by Warner Chilcott, it has been updated 10 times since 2008, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
10 versions recorded-
Nov 2025 — Present [monthly]
Terminated PHASE2
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Sep 2025 — Nov 2025 [monthly]
Terminated PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
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Jul 2022 — Jul 2024 [monthly]
Terminated PHASE2
▶ Show 5 earlier versions
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Jan 2021 — Jul 2022 [monthly]
Terminated PHASE2
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Jun 2018 — Jan 2021 [monthly]
Terminated PHASE2
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Dec 2017 — Jun 2018 [monthly]
Terminated PHASE2
Status: Suspended → Terminated
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Feb 2017 — Dec 2017 [monthly]
Suspended PHASE2
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Jan 2017 — Feb 2017 [monthly]
Suspended PHASE2
First recorded
Oct 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Warner Chilcott
For direct contact, visit the study record on ClinicalTrials.gov .