Status:
COMPLETED
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Lead Sponsor:
Eisai Inc.
Conditions:
Procedural Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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. W...
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 t...
Eligibility Criteria
Inclusion
- \- Number of sites/patients: Approximately 18 sites and 125 patients.
- Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
- 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.
- Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures at the time of screening.
- 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.
- Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
Exclusion
- Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
- Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
- 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.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
- Patient has participated in an investigational drug study within 1 month prior to study start.
- Patient is unwilling to adhere to pre- and postprocedural instructions.
- Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00327392
Start Date
May 1 2006
End Date
December 1 2007
Last Update
June 20 2012
Active Locations (15)
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1
Precision Trials
Phoenix, Arizona, United States, 85032
2
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
Medical Research Institute, Inc.
Slidell, Louisiana, United States, 70458