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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00261599
First received: December 1, 2005
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Conscious Sedation
Drug: AQUAVAN® (fospropofol disodium) Injection
Drug: Midazolam HCI
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 Phase 3, Randomized, Double-Blind, Dose-Controlled Study to Assess the Efficacy and Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal to Moderate Sedation in Patients Undergoing Colonoscopy

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Sedation Success - 3 consecutive modified OAA/S scores of ≤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

Estimated Enrollment: 300
Study Start Date: March 2006
Study Completion Date: October 2006
Detailed Description:

This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of a moderate dose of AQUAVAN compared to a subtherapeutic dose of AQUAVAN,both following pretreatment with an analgesic fentanyl, in patients who are undergoing elective 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Number of patients/site: Approximately 300 patients at up to 30 sites will be randomized into this study.
  • Study Country Location: United States

Inclusion Criteria:

  1. Patient must be able to understand required assessments and procedures.
  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:

  1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261599

Locations
United States, Alabama
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, California
UCSF-Fresno/University Medical Center
Fresno, California, United States, 93702
United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
United States, Illinois
Rockford Gastroenterology Associates
Rockford, Illinois, United States, 61107
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713
Indiana University Medical Center/Clarian Health Partner
Indianapolis, Indiana, United States, 46202
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Maryland Digestive Diseases Center
Laurel, Maryland, United States, 20707
Shah Associates
Prince Frederick, Maryland, United States, 20678
United States, Michigan
Oakland Colon & Rectal Associates
Royal Oak, Michigan, United States, 48067
Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Mississippi
Gastrointestinal Associates, PA
Jackson, Mississippi, United States, 39202
United States, New York
Research Associates of New York (New York Gastroenterology Associates)
New York, New York, United States, 10021
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
United States, Oregon
WestHills Gastroenterology Associates
Portland, Oregon, United States, 97225
United States, Tennessee
Memphis Gastroenterology Group, PC
Germantown, Tennessee, United States, 38138
Gastrointestinal Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Alamo Research Center
San Antonio, Texas, United States, 78215
United States, Washington
Spokane Digestive Disease Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Wisconsin Center for Advance Research
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: James Jones, MD, PharmD Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261599     History of Changes
Other Study ID Numbers: 3000-0522, MGI 3000-0522
Study First Received: December 1, 2005
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Colonoscopy
Sedation
AQUAVAN
Fospropofol disodium
Colon polyps
Endoscopic outcomes
Endoscopic sedation
Endoscopy

Additional relevant MeSH terms:
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 17, 2014