deltatrials
Terminated PHASE2 INTERVENTIONAL 4-arm NCT00578097

Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder

A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.

Sponsor: Ipsen

Updated 10 times since 2017 Last updated: Nov 21, 2019 Started: Feb 29, 2008 Primary completion: Jun 30, 2009 Completion: Dec 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated early due to poor recruitment.

This PHASE2 trial investigates Overactive Bladder and is currently terminated or withdrawn. Ipsen leads this study, which shows 10 recorded versions since 2008 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshotTerminated~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshotTerminated~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshotTerminated~Sep 2019 – ~Dec 2019 · 3 months · monthly snapshotTerminated~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Dec 2019 — Jan 2021 [monthly]

    Terminated PHASE2

Show 5 earlier versions
  1. Sep 2019 — Dec 2019 [monthly]

    Terminated PHASE2

  2. Aug 2019 — Sep 2019 [monthly]

    Terminated PHASE2

  3. Feb 2019 — Aug 2019 [monthly]

    Terminated PHASE2

  4. Jun 2018 — Feb 2019 [monthly]

    Terminated PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE2

    First recorded

Feb 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ipsen
Data source: Ipsen

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