Status:
COMPLETED
An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy
Lead Sponsor:
Eisai Inc.
Conditions:
Bronchoscopy
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Very often patients receive 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. Du...
Detailed Description
This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6.5 mg/kg compared to a minimally effective dose of AQUAVAN 2.0 mg/kg, both f...
Eligibility Criteria
Inclusion
- 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 of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age 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 Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
- 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 :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00306722
Start Date
April 1 2006
End Date
May 1 2007
Last Update
November 7 2008
Active Locations (25)
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1
Pulmonary Associates of Mobile, PC
Mobile, Alabama, United States, 36608
2
Precision Trials
Phoenix, Arizona, United States, 85032
3
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
4
USC Health Science Campus (USC University Hospital)
Los Angeles, California, United States, 90033