Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy; Colonic Polyps
Intervention: AQUAVAN® (fospropofol disodium) Injection (Drug); Midazolam HCl (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s): James Jones, PharmD, MD, Study Director, Affiliation: Eisai Inc.
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.
Clinical Details
Official title: A Randomized, Double-Blind, Dose-Response Study to Assess the Efficacy and Safety of AQUAVAN® Injection for Procedural Sedation in Patients Undergoing Colonoscopy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Three consecutive MOAA/S scores ≤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
Secondary outcome: Patient's rating of experience after ready for dischargePrincipal Investigator's (PI's) rating at end of procedure Percentage of patients requiring alternative sedative medication Number of doses/amount of fentanyl administered Number of doses of study medication administered Time to sedation, digital rectal examination, start of procedure, reach splenic flexure, hepatic flexure, cecum, end of procedure, and ready for discharge Percentage of patients requiring repositioning Percentage of patients whose procedures are interrupted due to inadequate sedation Time to ready for discharge from end of procedure Change from baseline DSST score over time during recovery period Patient's rating at 24 hour post discharge telephone survey Duration and percent of time when a patient's MOAA/S score is at each level between the first dose of study medications and fully alert and during the procedure PI's rating of level of sedation prior to initiation of the procedure Percentage of patients with a mean MOAA/S of 2 to 4 and 0 to 1 during the procedure MOAA/S over time
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites will
be randomized into this study.
- Study Country Location: United States
- Study Population: Male and female patients aged 18 years and older and undergoing
elective colonoscopy will be enrolled in the study.
Inclusion Criteria:
1. 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
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 or
lactating and has 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
4. 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, narcotic, or benzodiazepine
2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's
guidelines
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 12-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 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
Locations and Contacts
Clinical Research Associates, Huntsville, Alabama 35801, United States
Arizona Research Center, Phoenix, Arizona 85023, United States
Atlanta Gastroenterology Associates, Atlanta, Georgia 30342, United States
Rockford Gastroenterology Associates Ltd., Rockford, Illinois 61107, United States
Welborn Clinic, Evansville, Indiana 47713, United States
Gulf Coast Research Associates, Inc., Baton Rouge, Louisiana 70808, United States
Gastroenterology Clinic, Monroe, Louisiana 71201, United States
Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States
Endoscopic Microsurgery Associates, PA, Towson, Maryland 21204, United States
Gastrointestinal Associates, PA, Jackson, Mississippi 39202, United States
Winthrop-University Hospital, Mineola, New York 11501, United States
Research Associates of New York, New York, New York 10021, United States
Asheville Gastroenterology Associates/The Endoscopy Center, Asheville, North Carolina 28801, United States
Oklahoma Gastroenterology Associates, Tulsa, Oklahoma 74104, United States
Memphis Gastroenterology Group, PC, Memphis, Tennessee 38120, United States
Gastrointestinal Institute, Nashville, Tennessee 37203, United States
St. Thomas Medical Group, P.C., Nashville, Tennessee 37205, United States
Alamo Research Center, San Antonio, Texas 78215, United States
Spokane Digestive Diseases Center, Spokane, Washington 99207, United States
Wisconsin Center for Advance Research, Milwaukee, Wisconsin 53215, United States
Additional Information
Starting date: July 2005
Last updated: November 6, 2008
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