Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306722
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2006-03-22
Brief Title:
An Effectiveness and Safety Study of AQUAVAN Injection Fospropofol Disodium for Sedation During Flexible Bronchoscopy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Dose-Controlled Study To Assess The Efficacy And Safety Of AQUAVAN Fospropofol Disodium Injection For Minimal-To-Moderate Sedation In Patients Undergoing Flexible Bronchoscopy
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Very often patients receive medication before a diagnostic therapeutic or surgical procedure to help them relax keep them calm and to relieve them from pain This is called procedural sedation During procedural mild-to-moderate sedation a patient is first given a pain-relief medication analgesic and then a medication to help himher relax and keep himher calm sedative Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation AQUAVAN fospropofol disodium is made as a slow release version of propofol with a longer duration of effect
Detailed Description:
This is a phase 3 randomized double-blind dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 65 mgkg compared to a minimally effective dose of AQUAVAN 20 mgkg both following pretreatment with an analgesic fentanyl in patients who are undergoing flexible bronchoscopy
Following completion of preprocedure assessments patients will be randomly assigned to 1 of 2 treatment groups at a 23 AQUAVAN initial dose 1 20 mgkgAQUAVAN initial dose 2 65 mgkg allocation ratio on the day of the scheduled procedure Randomization will be stratified by site
A person skilled in airway management such as a respiratory therapist a study nurse or a clinician and authorized by the facility in which the colonoscopy is performed must be immediately available during the conduct of the study All patients will be placed on supplemental oxygen via nasal cannula 4 Lmin and an ECG monitor pulse oximeter and blood pressure monitor will be attached prior to administration of study medication All patients will receive analgesic pretreatment fentanyl citrate injection for pain lidocaine for topical anesthetic followed by the administration of study medication Assessments will be made to evaluate the patients for levels of sedation clinical benefit of sedation and adverse events Blood samples will be collected for PK analysis
Following completion of preprocedure assessments patients will be randomly assigned to 1 of 2 treatment groups at a 23 AQUAVAN initial dose 1 20 mgkgAQUAVAN initial dose 2 65 mgkg allocation ratio on the day of the scheduled procedure Randomization will be stratified by site
A person skilled in airway management such as a respiratory therapist a study nurse or a clinician and authorized by the facility in which the colonoscopy is performed must be immediately available during the conduct of the study All patients will be placed on supplemental oxygen via nasal cannula 4 Lmin and an ECG monitor pulse oximeter and blood pressure monitor will be attached prior to administration of study medication All patients will receive analgesic pretreatment fentanyl citrate injection for pain lidocaine for topical anesthetic followed by the administration of study medication Assessments will be made to evaluate the patients for levels of sedation clinical benefit of sedation and adverse events Blood samples will be collected for PK analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MGI 3000-0524 | None | None | None |