Status:
COMPLETED
Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy
Lead Sponsor:
Eisai Inc.
Conditions:
Colonoscopy
Colonic Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Very often, patients receive sedative 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 se...
Detailed Description
This is a randomized, double-blind study designed to evaluate the dose-response in the sedation success rate for 4 different initial bolus doses of AQUAVAN following pretreatment with an analgesic, fe...
Eligibility Criteria
Inclusion
- \- Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites will be randomized into this study.
- \- Study Country Location: United States
- \- Study Population: Male and female patients aged 18 years and older and undergoing elective colonoscopy will be enrolled in the study.
- 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 has 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, narcotic, or benzodiazepine
- Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guidelines
- 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 12-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 post-procedural instructions
- Patient for whom the use of fentanyl is contraindicated
- Patient for whom the use of Midazolam HCl injection (Midazolam) is contraindicated
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00125424
Start Date
July 1 2005
End Date
September 1 2005
Last Update
November 7 2008
Active Locations (20)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
4
Rockford Gastroenterology Associates Ltd.
Rockford, Illinois, United States, 61107