Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy

Last updated: November 6, 2008
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

2/3

Condition

Colon Cancer Screening

Polyps

Colon Polyps

Treatment

N/A

Clinical Study ID

NCT00125424
3000-0520
GPI 3000-0520
  • Ages > 18
  • All Genders

Study Summary

Very often, patients receive sedative 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, allowing for fast sedation and possibly faster recovery and discharge.

This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate (procedural) sedation.

Eligibility Criteria

Inclusion

  • Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites willbe randomized into this study.

  • Study Country Location: United States

  • Study Population: Male and female patients aged 18 years and older and undergoingelective colonoscopy will be enrolled in the study. Inclusion Criteria:

  1. Patient provides signed/dated informed consent and Health Insurance Portability andAccountability Act of 1996 (HIPAA) authorization after receiving a full explanation ofthe extent and nature of the study

  2. Patient must be at least 18 years of age at the time of screening

  3. If female, patient must be surgically sterile, postmenopausal, or not pregnant orlactating and has been using an acceptable method of birth control for at least 1month prior to dosing, with a negative urine pregnancy test result at screening andpre-dose

  4. Patient meets American Society of Anesthesiologists (ASA) Physical ClassificationSystem status of P1 to P4

Exclusion

Exclusion Criteria:

  1. Patient has a history of allergic reaction or hypersensitivity to any anestheticagent, narcotic, or benzodiazepine

  2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution'sguidelines

  3. Patient has a Mallampati classification score of 4; OR a Mallampati classificationscore of 3 AND a thyromental distance <= 4 cm, or for any other reason has a difficultairway, in the opinion of the Investigator

  4. Patient has an abnormal, clinically significant 12-lead ECG finding at predosingperiod Day 0

  5. Patient has participated in an investigational drug study within 1 month prior tostudy start

  6. Patient is unwilling to adhere to pre- and post-procedural instructions

  7. Patient for whom the use of fentanyl is contraindicated

  8. Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated

Study Design

Total Participants: 125
Study Start date:
July 01, 2005
Estimated Completion Date:
September 30, 2005

Study Description

This is a randomized, double-blind study designed to evaluate the dose-response in the sedation success rate for 4 different initial bolus doses of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients undergoing a 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 5 IV treatment groups at an equal allocation ratio (25 patients per arm) on the day of the scheduled procedure. Randomization will be stratified by age and ASA status:

AQUAVAN initial bolus dose 1: 8 mg/kg AQUAVAN initial bolus dose 2: 6.5 mg/kg AQUAVAN initial bolus dose 3: 5 mg/kg AQUAVAN initial bolus dose 4: 2 mg/kg Midazolam initial bolus dose: 0.02 mg/kg

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 a 12-lead electrocardiogram (ECG), pulse oximeter, and blood pressure monitor prior to administration of study medication. All patients will receive an injection of analgesic pretreatment followed by the administration of sedative medication, as described below. This protocol recognizes 2 distinct phases of sedation: Sedation Initiation and Sedation Maintenance. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit, and adverse events as detailed in the protocol. Blood samples will be collected for pharmacokinetic (PK) analysis, also detailed in the protocol.

Connect with a study center

  • Clinical Research Associates

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Rockford Gastroenterology Associates Ltd.

    Rockford, Illinois 61107
    United States

    Site Not Available

  • Welborn Clinic

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Gulf Coast Research Associates, Inc.

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Gastroenterology Clinic

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Endoscopic Microsurgery Associates, PA

    Towson, Maryland 21204
    United States

    Site Not Available

  • Gastrointestinal Associates, PA

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Winthrop-University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Research Associates of New York

    New York, New York 10021
    United States

    Site Not Available

  • Asheville Gastroenterology Associates/The Endoscopy Center

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Oklahoma Gastroenterology Associates

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Memphis Gastroenterology Group, PC

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Gastrointestinal Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • St. Thomas Medical Group, P.C.

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Alamo Research Center

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Spokane Digestive Diseases Center

    Spokane, Washington 99207
    United States

    Site Not Available

  • Wisconsin Center for Advance Research

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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