A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

May 17, 2012 updated by: Eisai Inc.

A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures

Very often patients receive medications 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. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2
  • 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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Slidell, Louisiana, United States, 70458
        • Medical Research Institute
      • Slidell, Louisiana, United States, 70458
        • Medical Research Institute, Inc.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Pasadena, Maryland, United States, 21122
        • Chesapeake Research Group, Llc
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Louis Women's Healthcare Group
    • Montana
      • Missoula, Montana, United States, 59802
        • International Heart Institute of Montana
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology, PC
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Southern Orthopaedic Sports Medicine
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
    • Utah
      • Sandy, Utah, United States, 84070
        • Physicians' Research Options

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

- Number of sites/patients: Approximately 18 sites and 125 patients.

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 (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
  3. Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures 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 Principal Investigator.
  4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
  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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
Time Frame: 2 hours
2 hours

Collaborators and Investigators

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

Sponsor

Eisai Inc.

Investigators

  • Study Director: James B Jones, MD, PharmD, Eisai Inc.

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

May 1, 2006

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

May 16, 2006

First Submitted That Met QC Criteria

May 16, 2006

First Posted (ESTIMATE)

May 18, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3000-0523

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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