Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedat… (NCT02800590) | Clinical Trial Compass
CompletedPhase 2
Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy
Netherlands150 participantsStarted 2016-05
Plain-language summary
This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult participants undergoing elective colonoscopy for screening or diagnostic purposes. This study is designed to test various ABP-700 infusion regimens for rational selection of one or more dosage regimen(s) to be used for future clinical development of ABP-700 in procedural sedation.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be male or female 18 to 75 years of age, inclusive
* Participant must give written informed consent before initiation of any study-related procedures
* Participant is scheduled to undergo elective colonoscopy
* Body Mass Index (BMI) 18.0 to 29.0 kilogram per meter squared (kg/m\^2)
* American Society of Anesthesiology (ASA) class I to II
* Modified Mallampati score I to II
* If female and of child-bearing potential, participant must have a negative pregnancy test during screening and cannot be breast-feeding
* If participant is a sexually active male or a sexually active female of child-bearing potential, he or she must agree to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
Exclusion Criteria:
* 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 milliseconds \[msec\]); 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 investigator, might confound the results of th…
What they're measuring
1
Number of Successfully Completed Procedures by Assigned ABP-700 Infusion Dose