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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00327392
Other study ID # 3000-0523
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 16, 2006
Last updated May 17, 2012
Start date May 2006
Est. completion date December 2007

Study information

Verified date May 2012
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
AQUAVAN® (fospropofol disodium) Injection


Locations

Country Name City State
United States St. Louis Women's Healthcare Group Chesterfield Missouri
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States Southern Orthopaedic Sports Medicine Columbia South Carolina
United States Dallas VA Medical Center Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Borland-Groover Clinic Jacksonville Florida
United States University of Louisville Louisville Kentucky
United States International Heart Institute of Montana Missoula Montana
United States Carolina Urologic Research Myrtle Beach South Carolina
United States Chesapeake Research Group, LLC Pasadena Maryland
United States Precision Trials Phoenix Arizona
United States Hudson Valley Urology, PC Poughkeepsie New York
United States Physicians' Research Options Sandy Utah
United States Medical Research Institute Slidell Louisiana
United States Medical Research Institute, Inc. Slidell Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures 2 hours Yes
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