An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
NCT ID: NCT00261599
Last Updated: 2008-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2006-03-31
2006-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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AQUAVAN® (fospropofol disodium) Injection
Midazolam HCI
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Principal Investigators
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James Jones, MD, PharmD
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Clinical Research Associates
Huntsville, Alabama, United States
UCSF-Fresno/University Medical Center
Fresno, California, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Rockford Gastroenterology Associates
Rockford, Illinois, United States
Welborn Clinic
Evansville, Indiana, United States
Indiana University Medical Center/Clarian Health Partner
Indianapolis, Indiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Maryland Digestive Diseases Center
Laurel, Maryland, United States
Shah Associates
Prince Frederick, Maryland, United States
Oakland Colon & Rectal Associates
Royal Oak, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, United States
Research Associates of New York (New York Gastroenterology Associates)
New York, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
WestHills Gastroenterology Associates
Portland, Oregon, United States
Memphis Gastroenterology Group, PC
Germantown, Tennessee, United States
Gastrointestinal Institute
Nashville, Tennessee, United States
Alamo Research Center
San Antonio, Texas, United States
Spokane Digestive Disease Center
Spokane, Washington, United States
Wisconsin Center for Advance Research
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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MGI 3000-0522
Identifier Type: -
Identifier Source: secondary_id
3000-0522
Identifier Type: -
Identifier Source: org_study_id