Phase
Condition
Colon Cancer Screening
Polyps
Colon Polyps
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Number of Patients/Site: Approximately 125 patients, 25 per arm, at up to 25 sites willbe randomized into this study.
Study Country Location: United States
Study Population: Male and female patients aged 18 years and older and undergoingelective colonoscopy will be enrolled in the study. Inclusion Criteria:
Patient provides signed/dated informed consent and Health Insurance Portability andAccountability Act of 1996 (HIPAA) authorization after receiving a full explanation ofthe 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 orlactating and has been using an acceptable method of birth control for at least 1month prior to dosing, with a negative urine pregnancy test result at screening andpre-dose
Patient meets American Society of Anesthesiologists (ASA) Physical ClassificationSystem status of P1 to P4
Exclusion
Exclusion Criteria:
Patient has a history of allergic reaction or hypersensitivity to any anestheticagent, narcotic, or benzodiazepine
Patient does not meet nils per os (NPO) status per ASA guidelines or institution'sguidelines
Patient has a Mallampati classification score of 4; OR a Mallampati classificationscore of 3 AND a thyromental distance <= 4 cm, or for any other reason has a difficultairway, in the opinion of the Investigator
Patient has an abnormal, clinically significant 12-lead ECG finding at predosingperiod Day 0
Patient has participated in an investigational drug study within 1 month prior tostudy 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
Study Design
Study Description
Connect with a study center
Clinical Research Associates
Huntsville, Alabama 35801
United StatesSite Not Available
Arizona Research Center
Phoenix, Arizona 85023
United StatesSite Not Available
Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
United StatesSite Not Available
Rockford Gastroenterology Associates Ltd.
Rockford, Illinois 61107
United StatesSite Not Available
Welborn Clinic
Evansville, Indiana 47713
United StatesSite Not Available
Gulf Coast Research Associates, Inc.
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Gastroenterology Clinic
Monroe, Louisiana 71201
United StatesSite Not Available
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Endoscopic Microsurgery Associates, PA
Towson, Maryland 21204
United StatesSite Not Available
Gastrointestinal Associates, PA
Jackson, Mississippi 39202
United StatesSite Not Available
Winthrop-University Hospital
Mineola, New York 11501
United StatesSite Not Available
Research Associates of New York
New York, New York 10021
United StatesSite Not Available
Asheville Gastroenterology Associates/The Endoscopy Center
Asheville, North Carolina 28801
United StatesSite Not Available
Oklahoma Gastroenterology Associates
Tulsa, Oklahoma 74104
United StatesSite Not Available
Memphis Gastroenterology Group, PC
Memphis, Tennessee 38120
United StatesSite Not Available
Gastrointestinal Institute
Nashville, Tennessee 37203
United StatesSite Not Available
St. Thomas Medical Group, P.C.
Nashville, Tennessee 37205
United StatesSite Not Available
Alamo Research Center
San Antonio, Texas 78215
United StatesSite Not Available
Spokane Digestive Diseases Center
Spokane, Washington 99207
United StatesSite Not Available
Wisconsin Center for Advance Research
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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