A phase II, two-part, multiple-dose, dose-finding, single-blind study to investigate the safety and efficacy of ABP-700 for procedural sedation in adult patients undergoing colonoscopy

The Medicines Company0 个研究点开始时间: 2016年4月4日最近更新: 2017年10月2日

适应症

试验速览

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•1. Patient must be male or female 18 -75 years of age, inclusive.
•2. Patient must give written informed consent before initiation of any study-related procedures
•3. Patient is scheduled to undergo elective colonoscopy
•4. BMI 18.0 – 29.0 kg/m2
•5. ASA class I – II
•6. Modified Mallampati score I – II
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Any ASA physical status III or worse, or history of one or more of the following:
•- History or presence of significant cardiovascular disease including atrial fibrillation, or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome, > 450 msec)
•- History of any neurological or seizure disorder or psychiatric disease
•- History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic or dermatologic disease
•- History of any illness that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the patient by their participation in the study
•2. History of any recent illness (e.g., upper respiratory infection) that does not satisfy ASA III or greater requirements but in the opinion of the PI, may pose an additional risk to the patient by their participation in the study.
•3. Patients with a history of essential hypertension that are not well on controlled on medication and/or have been diagnosed with hypertension for less than 6 months and/or are not on stable therapy for at least 4 weeks prior to the study

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