Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261599
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2005-12-01
Brief Title:
An Effectiveness and Safety Study of AQUAVAN Injection Fospropofol Disodium for Sedation During Colonoscopy
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 Colonoscopy
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 procedure like a colonoscopy to help them relax and stay calm during the procedure This is called procedural or minimal-to-moderate sedation One product used for sedation is called propofol AQUAVAN fospropofol disodium is made as a water soluble form of propofol allowing for rapid sedation during the entire procedure This study is designed to test AQUAVAN for sedation during colonoscopy procedures
Detailed Description:
This is a phase 3 randomized double-blind dose-controlled study designed to evaluate the efficacy and safety of a moderate dose of AQUAVAN compared to a subtherapeutic dose of AQUAVANboth following pretreatment with an analgesic fentanyl in patients who are undergoing elective colonoscopy A group of patients will receive midazolam as a reference therapy
Following completion of pre-procedure assessments patients will be randomly assigned to 1 of 3 treatment groups at a 231 AQUAVAN initial dose 1 subtherapeutic doseAQUAVAN initial dose 2 moderate dose initial Midazolam Reference Dose allocation ratio on the day of the scheduled procedure
A person skilled in airway management and authorized by the facility in which the colonoscopy is performed such as a respiratory therapist a study nurse or a clinician 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 an injection of analgesic pretreatment followed by the administration of study medication This protocol recognized 2 distinct phases of sedation Sedation Initiation and Sedation Maintenance 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 pre-procedure assessments patients will be randomly assigned to 1 of 3 treatment groups at a 231 AQUAVAN initial dose 1 subtherapeutic doseAQUAVAN initial dose 2 moderate dose initial Midazolam Reference Dose allocation ratio on the day of the scheduled procedure
A person skilled in airway management and authorized by the facility in which the colonoscopy is performed such as a respiratory therapist a study nurse or a clinician 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 an injection of analgesic pretreatment followed by the administration of study medication This protocol recognized 2 distinct phases of sedation Sedation Initiation and Sedation Maintenance 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 3000-0522 | None | None | None |