A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00327392
First received: May 16, 2006
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

Very often patients receive medications 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. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.


Condition Intervention Phase
Procedural Sedation
Drug: AQUAVAN® (fospropofol disodium) Injection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Enrollment: 123
Study Start Date: May 2006
Study Completion Date: December 2007
Detailed Description:

This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

- Number of sites/patients: Approximately 18 sites and 125 patients.

Inclusion Criteria:

  1. Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
  2. Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
  3. Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures 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 predose.
  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 or opioid.
  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 Principal Investigator.
  4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327392

Locations
United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Medical Research Institute, Inc.
Slidell, Louisiana, United States, 70458
Medical Research Institute
Slidell, Louisiana, United States, 70458
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Missouri
St. Louis Women's Healthcare Group
Chesterfield, Missouri, United States, 63017
United States, Montana
International Heart Institute of Montana
Missoula, Montana, United States, 59802
United States, New York
Hudson Valley Urology, PC
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, United States, 29204
Carolina Urologic Research
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
United States, Utah
Physicians' Research Options
Sandy, Utah, United States, 84070
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: James B Jones, MD, PharmD Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00327392     History of Changes
Other Study ID Numbers: 3000-0523
Study First Received: May 16, 2006
Results First Received: March 1, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Arthroscopy
AV Shunt
Bunion
Dilatation and Curettage
Esophagogastroduodenoscopy
Hysteroscopy
Lithotripsy
Rotator Cuff/ Shoulder
Transesophageal Echocardiography
Ureteroscopy
AQUAVAN
Sedation

Additional relevant MeSH terms:
Fospropofol disodium
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 24, 2014