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

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 Colonoscopy

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.

Study Overview

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 AQUAVAN,both 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 2:3:1 (AQUAVAN initial dose 1 [subtherapeutic dose]:AQUAVAN 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 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 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 Type

Interventional

Enrollment

300

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
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • California
      • Fresno, California, United States, 93702
        • UCSF-Fresno/University Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center/Clarian Health Partner
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Laurel, Maryland, United States, 20707
        • Maryland Digestive Diseases Center
      • Prince Frederick, Maryland, United States, 20678
        • Shah Associates
    • Michigan
      • Royal Oak, Michigan, United States, 48067
        • Oakland Colon & Rectal Associates
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Gastrointestinal Associates, PA
    • New York
      • New York, New York, United States, 10021
        • Research Associates of New York (New York Gastroenterology Associates)
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
    • Oregon
      • Portland, Oregon, United States, 97225
        • WestHills Gastroenterology Associates
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Memphis Gastroenterology Group, PC
      • Nashville, Tennessee, United States, 37203
        • Gastrointestinal Institute
    • Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Research Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Digestive Disease Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advance Research

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 patients/site: Approximately 300 patients at up to 30 sites will be randomized into this study.
  • Study Country Location: United States

Inclusion Criteria:

  1. Patient must be able to understand 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 pre-dose.
  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, opioid, or benzodiazepine.
  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.
  8. Patient for whom the use of midazolam HCl injection (midazolam) 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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sedation Success - 3 consecutive modified OAA/S scores of ≤4 after administration of sedative medication AND completing the procedure without requiring the use of alternative sedative medication AND without requiring manual or mechanical ventilation

Collaborators and Investigators

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

Sponsor

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

March 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (Estimate)

December 5, 2005

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

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.

Clinical Trials on Conscious Sedation

Clinical Trials on AQUAVAN® (fospropofol disodium) Injection

Subscribe