An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy

Completed · Phase 3

Conditions studied: Conscious Sedation

In brief

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.

Key facts

Study ID

NCT00261599

Run by

Eisai Inc.

People needed

300

Starts

2006-03-01

Expected to finish

2006-10-01

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 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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