At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
In Brief
A Phase 4 clinical trial evaluating fospropofol disodium Subgroup 1 Lower Dose, fospropofol disodium Subgroup 1 Approved Dose, and 4 other interventions for Sedation. Completed, enrolled 153 participants across 23 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
Study Details
Timeline
Interventions
Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight \< 60 kg and Age \< 65 years and ASAI and II)
(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight \<60 kg and Age \<65 years and ASAI and II)
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight \< 60 kg and Age \>/=65 years and ASA 3 or 4
(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight \<60 kg and Age \>/=65 years and ASA 3 or 4
(Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight \>/= 60 kg and Age \>/= 65 years and ASA 3 or 4
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight \>/= 60 kg and Age \>/= 65 years and ASA 3 or 4