Status:
COMPLETED
An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
Lead Sponsor:
Eisai Inc.
Conditions:
Conscious Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 sedati...
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 followin...
Eligibility Criteria
Inclusion
- Number of patients/site: Approximately 300 patients at up to 30 sites will be randomized into this study.
- Study Country Location: United States
- Patient must be able to understand 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 pre-dose.
- 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, opioid, or benzodiazepine.
- 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.
- Patient for whom the use of midazolam HCl injection (midazolam) is contraindicated.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00261599
Start Date
March 1 2006
End Date
October 1 2006
Last Update
November 7 2008
Active Locations (20)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
UCSF-Fresno/University Medical Center
Fresno, California, United States, 93702
3
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
4
Rockford Gastroenterology Associates
Rockford, Illinois, United States, 61107