deltatrials
Terminated PHASE2 INTERVENTIONAL 3-arm NCT00712322

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

Interventions Darifenacin
Updated 10 times since 2017 Last updated: May 13, 2022 Started: Oct 7, 2008 Primary completion: May 23, 2013 Completion: May 23, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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Listed as NCT00712322, this PHASE2 trial focuses on Neurogenic Detrusor Overactivity and remains terminated or withdrawn.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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotSuspended~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshotSuspended~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2022 · 18 months · monthly snapshotTerminated~Jul 2022 – ~Jul 2024 · 24 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshotTerminated~Nov 2025 – present · 9 months · monthly snapshotTerminated

Change History

10 versions recorded
  1. Nov 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2025 — Nov 2025 [monthly]

    Terminated PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  5. Jul 2022 — Jul 2024 [monthly]

    Terminated PHASE2

Show 5 earlier versions
  1. Jan 2021 — Jul 2022 [monthly]

    Terminated PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  3. Dec 2017 — Jun 2018 [monthly]

    Terminated PHASE2

    Status: SuspendedTerminated

  4. Feb 2017 — Dec 2017 [monthly]

    Suspended PHASE2

  5. 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

Sponsor contact:
  • Warner Chilcott
Data source: Warner Chilcott

For direct contact, visit the study record on ClinicalTrials.gov .