deltatrials
Terminated PHASE4 INTERVENTIONAL 3-arm NCT01195103

Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery

A Prospective Randomized Study to Assess the Efficacy and Safety of Bolus-dose Lusedra (Fospropofol Disodium) 6.5 mg/kg or 10 mg/kg Versus a Placebo (With Midazolam Rescue) for Minimal-to-moderate Sedation in Patients Undergoing Procedural Sedation for Regional Anesthesia Blocks Prior to Orthopedic Surgery

Sponsor: Eisai Inc.

Updated 7 times since 2017 Last updated: Jun 25, 2012 Started: Feb 28, 2011 Primary completion: Mar 31, 2011 Completion: Mar 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Funding terminated by funding source.

Listed as NCT01195103, this PHASE4 trial focuses on Orthopedic Surgery and Procedural Sedation and remains terminated or withdrawn. Sponsored by Eisai Inc., it has been updated 7 times since 2011, reflecting limited 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 snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE4

  2. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE4

    First recorded

Feb 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eisai Inc.
  • Mayo Clinic
Data source: Mayo Clinic

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

Study Locations