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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00125424
First received: July 27, 2005
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Colonic Polyps
Drug: AQUAVAN® (fospropofol disodium) Injection
Drug: Midazolam HCl
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 Measures:
  • 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
  • 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

Estimated Enrollment: 125
Study Start Date: July 2005
Study Completion Date: September 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125424

Locations
United States, Alabama
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Rockford Gastroenterology Associates Ltd.
Rockford, Illinois, United States, 61107
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713
United States, Louisiana
Gulf Coast Research Associates, Inc.
Baton Rouge, Louisiana, United States, 70808
Gastroenterology Clinic
Monroe, Louisiana, United States, 71201
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Endoscopic Microsurgery Associates, PA
Towson, Maryland, United States, 21204
United States, Mississippi
Gastrointestinal Associates, PA
Jackson, Mississippi, United States, 39202
United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
Research Associates of New York
New York, New York, United States, 10021
United States, North Carolina
Asheville Gastroenterology Associates/The Endoscopy Center
Asheville, North Carolina, United States, 28801
United States, Oklahoma
Oklahoma Gastroenterology Associates
Tulsa, Oklahoma, United States, 74104
United States, Tennessee
Memphis Gastroenterology Group, PC
Memphis, Tennessee, United States, 38120
Gastrointestinal Institute
Nashville, Tennessee, United States, 37203
St. Thomas Medical Group, P.C.
Nashville, Tennessee, United States, 37205
United States, Texas
Alamo Research Center
San Antonio, Texas, United States, 78215
United States, Washington
Spokane Digestive Diseases Center
Spokane, Washington, United States, 99207
United States, Wisconsin
Wisconsin Center for Advance Research
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: James Jones, PharmD, MD Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125424     History of Changes
Other Study ID Numbers: 3000-0520, GPI 3000-0520
Study First Received: July 27, 2005
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Colonoscopy
Sedation
AQUAVAN
(fospropofol disodium)
Endoscopic sedation
Endoscopic outcomes
Endoscopy

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Midazolam
Fospropofol disodium
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014