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

Completed · Phase 2/Phase 3

Conditions studied: Colonoscopy, Colonic Polyps

In brief

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.

Key facts

Study ID

NCT00125424

Run by

Eisai Inc.

People needed

125

Starts

2005-07-01

Expected to finish

2005-09-01

Last updated by the study team

2008-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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
• Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4

You may not qualify if…

• Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine
• Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines
• 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 12-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 post-procedural instructions
• Patient for whom the use of fentanyl is contraindicated
• Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Rockford Gastroenterology Associates Ltd. — Rockford, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• Gulf Coast Research Associates, Inc. — Baton Rouge, Louisiana, United States
• Gastroenterology Clinic — Monroe, Louisiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Endoscopic Microsurgery Associates, PA — Towson, Maryland, United States
• Gastrointestinal Associates, PA — Jackson, Mississippi, United States
• Winthrop-University Hospital — Mineola, New York, United States
• Research Associates of New York — New York, New York, United States
• Asheville Gastroenterology Associates/The Endoscopy Center — Asheville, North Carolina, United States
• Oklahoma Gastroenterology Associates — Tulsa, Oklahoma, United States
• Memphis Gastroenterology Group, PC — Memphis, Tennessee, United States
• Gastrointestinal Institute — Nashville, Tennessee, United States
• St. Thomas Medical Group, P.C. — Nashville, Tennessee, United States
• Alamo Research Center — San Antonio, Texas, United States
• Spokane Digestive Diseases Center — Spokane, Washington, United States
• Wisconsin Center for Advance Research — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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