The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
541
solution for oral administration prior to colonoscopy
solution for oral administration prior to colonoscopy
solution for oral administration prior to colonoscopy
University of South Alabama
Mobile, Alabama, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Percentage of Subjects With Successful Bowel Preparation
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
Time frame: Day of colonoscopy
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy
Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken).
Time frame: 2 days
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7
Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days).
Time frame: 7 days
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