An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
Information source: MGI Pharma
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conscious Sedation
Intervention: AQUAVAN® (fospropofol disodium) Injection (Drug); Midazolam HCI (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: MGI Pharma Official(s) and/or principal investigator(s):
James Jones, MD, PharmD, Study Director, Affiliation: MGI Pharma
Summary
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
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 subtherapuetic 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 [subtherapuetic 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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:
Patient must be able to understand 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 pre-dose.
Patient meets American Society of Anesthesiologists (ASA) Physical Classification System
status of P1 to P4.
Exclusion Criteria:
Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent,
opioid, or benzodiazepine.
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.
Patient for whom the use of midazolam HCl injection (midazolam) is contraindicated.
Locations and Contacts
Clinical Research Associates, Huntsville, Alabama 35801, United States
UCSF-Fresno/University Medical Center, Fresno, California 93702, United States
Borland-Groover Clinic, Jacksonville, Florida 32256, United States
Rockford Gastroenterology Associates, Rockford, Illinois 61107, United States
Welborn Clinic, Evansville, Indiana 47713, United States
Indiana University Medical Center/Clarian Health Partner, Indianapolis, Indiana 46202, United States
Shah Associates, Prince Frederick, Maryland 20678, United States
Maryland Digestive Diseases Center, Laurel, Maryland 20707, United States
Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States
Center for Digestive Health, Troy, Michigan 48098, United States
Oakland Colon & Rectal Associates, Royal Oak, Michigan 48067, United States
Gastrointestinal Associates, PA, Jackson, Mississippi 39202, United States
Research Associates of New York (New York Gastroenterology Associates), New York, New York 10021, United States
Asheville Gastroenterology Associates, Asheville, North Carolina 28801, United States
WestHills Gastroenterology Associates, Portland, Oregon 97225, United States
Memphis Gastroenterology Group, PC, Germantown, Tennessee 38138, United States
Gastrointestinal Institute, Nashville, Tennessee 37203, United States
Alamo Research Center, San Antonio, Texas 78215, United States
Spokane Digestive Disease Center, Spokane, Washington 99204, United States
Wisconsin Center for Advance Research, Milwaukee, Wisconsin 53215, United States
Additional Information
Starting date: March 2006
Ending date: October 2006
Last updated: September 11, 2007
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