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

NCT00125424 | Completed Phase 2

• 2 other identifiers: 3000-0520GPI 3000-0520
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Colonoscopy; Colonic Polyps

Keywords

Colonoscopy; Sedation; AQUAVAN; (fospropofol disodium); Endoscopic sedation; Endoscopic outcomes; Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Patient's rating of experience after ready for discharge

• Principal 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

Interventions

AQUAVAN® (fospropofol disodium) Injection DRUG

Midazolam HCl DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (20)

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Rockford Gastroenterology Associates Ltd.

Rockford, Illinois, 61107, United States

Location

Welborn Clinic

Evansville, Indiana, 47713, United States

Location

Gulf Coast Research Associates, Inc.

Baton Rouge, Louisiana, 70808, United States

Location

Gastroenterology Clinic

Monroe, Louisiana, 71201, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Endoscopic Microsurgery Associates, PA

Towson, Maryland, 21204, United States

Location

Gastrointestinal Associates, PA

Jackson, Mississippi, 39202, United States

Location

Winthrop-University Hospital

Mineola, New York, 11501, United States

Location

Research Associates of New York

New York, New York, 10021, United States

Location

Asheville Gastroenterology Associates/The Endoscopy Center

Asheville, North Carolina, 28801, United States

Location

Oklahoma Gastroenterology Associates

Tulsa, Oklahoma, 74104, United States

Location

Memphis Gastroenterology Group, PC

Memphis, Tennessee, 38120, United States

Location

Gastrointestinal Institute

Nashville, Tennessee, 37203, United States

Location

St. Thomas Medical Group, P.C.

Nashville, Tennessee, 37205, United States

Location

Alamo Research Center

San Antonio, Texas, 78215, United States

Location

Spokane Digestive Diseases Center

Spokane, Washington, 99207, United States

Location

Wisconsin Center for Advance Research

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

fospropofol; Injections; Midazolam

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• James Jones, PharmD, MD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: August 1, 2005
• Study Start: July 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 7, 2008

Record last verified: 2008-11

Locations

US (20)