An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy
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
2 other identifiers
interventional
250
1 country
25
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 him/her relax and keep him/her 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2006
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 7, 2008
November 1, 2008
March 22, 2006
November 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Sedation Success rate is defined as: Having 3 consecutive Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale scores of ≤4 after administration of sedative medication
Completing the procedure
Without requiring the use of alternative sedative medication
Without requiring manual or mechanical ventilation
Secondary Outcomes (3)
Treatment Success rate - Treatment Success is defined as a patient (i) completing the procedure (ii) without requiring alternative sedative medications AND (iii) without requiring manual or mechanical ventilation
Proportion of patients willing to be treated again with the same study sedative medication
Proportion of patients who do not recall being awake during the procedure
Interventions
Eligibility Criteria
You may qualify if:
- Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures
- Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age at the time of screening.
- If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose.
- Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
You may not qualify if:
- Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
- Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
- Patient has a Mallampati Classification Score of 4; OR a Mallampati Classification Score of 3 AND a thyromental distance ≤4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
- Patient has participated in an investigational drug study within 1 month prior to study start.
- Patient is unwilling to adhere to pre- and postprocedural instructions.
- Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (25)
Pulmonary Associates of Mobile, PC
Mobile, Alabama, 36608, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
USC Health Science Campus (USC University Hospital)
Los Angeles, California, 90033, United States
Pensacola Research Consultants, Inc.
Pensacola, Florida, 32503, United States
Acute Care Consultants Inc.
Augusta, Georgia, 30909, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Central Maine Pulmonary Associates
Auburn, Maine, 04210, United States
Berkshire Medical Center
Pittsfield, Maryland, 01201, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Keith Popovich, MD, PLLC
Butte, Montana, 59701, United States
International Heart Institue of MT Foundation
Missoula, Montana, 59802, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
United Health Scrvices Hosptial, INC
Johnson City, New York, 13790, United States
Brody School of Medicine
Greenville, North Carolina, 27834, United States
ALL-TRIALS Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati, The University Hospital
Cincinnati, Ohio, 45267, United States
Lowcountry Lung & Critical Care, PA
Charleston, South Carolina, 29406, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
The University of Texas Medical Branch Division of APICS
Galveston, Texas, 77555, United States
Johnston Memorial Hospital Pulmonary Research
Abingdon, Virginia, 24210, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22401, United States
Related Publications (1)
Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH. A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy. Chest. 2009 Jan;135(1):41-47. doi: 10.1378/chest.08-0623. Epub 2008 Jul 18.
PMID: 18641105DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Jones, MD, PharmD
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2006
First Posted
March 24, 2006
Study Start
April 1, 2006
Study Completion
May 1, 2007
Last Updated
November 7, 2008
Record last verified: 2008-11