An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy

November 6, 2008 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Detailed Description

This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6.5 mg/kg compared to a minimally effective dose of AQUAVAN 2.0 mg/kg, 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 2:3 (AQUAVAN initial dose 1 [2.0 mg/kg]:AQUAVAN initial dose 2 [6.5 mg/kg] 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 L/min), 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 Type

Interventional

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pulmonary Associates of Mobile, PC
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • California
      • Laguna Hills, California, United States, 92653
        • Saddleback Memorial Medical Center
      • Los Angeles, California, United States, 90033
        • USC Health Science Campus (USC University Hospital)
    • Florida
      • Pensacola, Florida, United States, 32503
        • Pensacola Research Consultants, Inc.
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Acute Care Consultants Inc.
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
    • Maine
      • Auburn, Maine, United States, 04210
        • Central Maine Pulmonary Associates
    • Maryland
      • Pittsfield, Maryland, United States, 01201
        • Berkshire Medical Center
    • Michigan
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
    • Montana
      • Butte, Montana, United States, 59701
        • Keith Popovich, MD, PLLC
      • Missoula, Montana, United States, 59802
        • International Heart Institue of MT Foundation
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • Johnson City, New York, United States, 13790
        • United Health Scrvices Hosptial, INC
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine
      • Winston-Salem, North Carolina, United States, 27103
        • All-Trials Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati, The University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29406
        • Lowcountry Lung & Critical Care, PA
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
      • Spartanburg, South Carolina, United States, 29303
        • South Carolina Pharmaceutical Research
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch Division of APICS
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Johnston Memorial Hospital Pulmonary Research
      • Fredericksburg, Virginia, United States, 22401
        • Pulmonary Associates of Fredericksburg, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures
  2. 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.
  3. Patient must be at least 18 years of age at the time of screening.
  4. 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.
  5. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.

Exclusion Criteria:

  1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
  2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
  3. 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.
  4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
  5. Patient has participated in an investigational drug study within 1 month prior to study start.
  6. Patient is unwilling to adhere to pre- and postprocedural instructions.
  7. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (ESTIMATE)

March 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2008

Last Update Submitted That Met QC Criteria

November 6, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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