Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean®) with a polyethylene glycol/bisacodyl kit

Table 1 Study event schedule

	Screening visit	Randomization visit1	Regimen start	Colonoscopy visit	Follow-up visit
Visit	1	2		3	4
Day	-8 to -1	-8 to -1	1	2	9-16
Informed consent	X
Inclusion/exclusion	X	X
Medical history	X
Demographic data	X
Physical examination	X				X
Vital signs	X			X	X
Urine pregnancy test	X
12-Lead electrocardiogram	X				X
Renal function	X2			X3	X
Electrolytes	X2			X3	X
Randomization		X
Dietary control			X
Dispensing of study drug		X
Dosing day			X4	X
Dietary card			X	X
Subject questionnaire				X5
Colonoscopy				X
Aronchick scale				X6
Ottawa bowel preparation scale (OBPS)				X6
Bowel preparation compliance				X
Concomitant medication	X	X	X	X	X
Reported events7			X	X
Unsolicited adverse events and serious adverse events			X	X	X

¹Indicates that the screening day and randomization day could be the same. However, the activities listed for the Screening Visit had to be completed before randomization.

²Indicates that after obtaining baseline laboratory data, the subject was randomized if s/he did not meet exclusion criteria No. 9.

³Indicates that laboratory tests were performed after completion of investigation procedures and following the colonoscopy.

⁴Indicates that the first dosing day was scheduled to follow the dispensing of study drug instructions.

⁵Indicates that tolerability and satisfaction of the preparation was measured by a standardized subject questionnaire administered on the day of colonoscopy, prior to the procedure.

⁶Indicates that all colonoscopies were videorecorded. After the colonoscopy, independent blinded colonoscopists rated the video recordings for Aronchick Scale and Ottawa bowel preparation scale scores.

⁷Indicates that reported adverse events were recorded in the dietary card.