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.

Table 2 The primary endpoint of bowel cleansing efficacy as assessed by the Aronchick Scale (per-protocol analysis set)

	Quiklean®, n = 208	Klean-Prep/Dulcolax®, n = 209	P value
Responses
Successful (Excellent + Good)	205	204
Unsuccessful (Fair + Poor + Inadequate)	3	5
Success rate	98.6%	97.6%
Between-group difference	0.95%
95% exact CI	(-8.620%, 10.525%)
Rating, n (%)
Excellent	50 (24.0)	69 (33.0)	0.1355
Good	155 (74.5)	135 (64.6)
Fair	3 (1.4)	4 (1.9)
Poor	0	1 (0.5)
Inadequate	0	0

P value was obtained by Chi-Square test. CI: Confidence interval.

Table 3 The secondary endpoint of overall bowel cleansing efficacy as assessed by the Ottawa bowel preparation scale (per-protocol analysis set)

	Quiklean®, n = 208	Klean-Prep/Dulcolax®, n = 209	P value
Total bowel preparation score
mean ± SD	2.5 ± 1.48	2.5 ± 1.681	0.73332
Median (Min, Max)	3.0 (0, 7)	3.0 (0, 9)
Overall bowel cleansing quality, n (%)
Success (Excellent + Good + Fair)	208 (100)	206 (99)1	0.49883
Un-success (Poor + Inadequate)	0 (0)	2 (1)

¹Indicates that subject 1-S074-R1074 had previously undergone removal of an ascending colon segment.

²Indicates that P value was obtained by independent t-test.

³Indicates that P value was obtained by Fisher’s exact test. SD: Standard deviation.

Table 4 Acceptability and tolerability (per-protocol analysis set), n (%)

	Quiklean®, n = 208	Klean-Prep/Dulcolax®, n = 209	P value
1 How easy or difficult was it to consume the study drug?
Very easy	68 (32.7)	48 (23.0)	0.12011
Easy	96 (46.2)	110 (52.6)
Tolerable	23 (11.1)	25 (12.0)
Difficult	18 (8.7)	25 (12.0)
Very difficult	3 (1.4)	1 (0.5)
2 Were you able to consume the study preparation as instructed?
Yes	208 (100)	207 (99.0)	0.49882
No	0	2 (1.0)
3 Please describe your overall experience with the study preparation.
Excellent	50 (24.0)	36 (17.2)	0.00161
Good	112 (53.8)	109 (52.2)
Fair	21 (10.1)	12 (5.7)
Poor	24 (11.5)	43 (20.6)
Bad	1 (0.5)	9 (4.3)
4 The taste of this study preparation was
Excellent	48 (23.1)	28 (13.4)	< 0.00011
Good	82 (39.4)	82 (39.2)
Fair	41 (19.7)	17 (8.1)
Poor	35 (16.8)	65 (31.1)
Bad	2 (1.0)	17 (8.1)
5 Would you ask your doctor for this preparation again if you need another colonoscopy in the future?
Yes	167 (80.3)	152 (72.7)	0.08302
No	41 (19.7)	27.3)
6 Would you refuse the same preparation again if it were to be prescribed to you in the future?
Yes	42 (20.2)	54 (25.8)	0.20072
No	166 (79.8)	155 (74.2)

¹Indicates that P value was obtained by Cochran-Mantel-Haenszel test.

²Indicates that P value was obtained by Fisher’s exact test.

Table 5 Summary of treatment-emergent adverse events (safety analysis set), n (%)

Treatment-emergent adverse events	Quiklean®, n = 222	Klean-Prep/Dulcolax®, n = 220	P value
Any treatment-emergent adverse events	218 (98.2)	70 (31.8)	< 0.0001
Mild	217 (97.7)	70 (31.8)
Moderate	1 (0.5)	0
Severe	0	0
Life threatening	0	0
Death	0	0
MedDRA preferred term
Blood phosphorus increased	216 (97.3)	8 (3.6)	< 0.0001
Blood potassium decreased	109 (49.1)	9 (4.1)	< 0.0001
Blood phosphorus decreased	6 (2.7)	42 (19.1)	< 0.0001
Blood urea decreased	16 (7.2)	7 (3.2)	0.0847
Blood chloride decreased	14 (6.3)	8 (3.6)	0.2740
Blood chloride increased	6 (2.7)	7 (3.2)	0.7867
Blood calcium decreased	6 (2.7)	1 (0.5)	0.1221
Blood sodium decreased	7 (3.2)	0	0.0149
Blood creatinine decreased	2 (0.9)	1 (0.5)	1.0000
Blood urea increased	1 (0.5)	2 (0.9)	0.6224
Blood magnesium increased	2 (0.9)	0	0.4989
Blood sodium increased	1 (0.5)	1 (0.5)	1.0000
Blood creatinine increased	1 (0.5)	0	1.0000
Blood potassium increased	1 (0.5)	0	1.0000
Duodenal ulcer	0	1 (0.5)	0.4977
Nonalcoholic fatty liver disease	0	1 (0.5)	0.4977
Herpes zoster	0	1 (0.5)	0.4977
Pyoderma	0	1 (0.5)	0.4977
Muscle disorder	0	1 (0.5)	0.4977
Calculus urinary	1 (0.5)	0	1.0000
Asthma	1 (0.5)	0	1.0000
Rhinitis allergic	1 (0.5)	0	1.0000

P value: Between-group differences were compared using the Fisher’s exact test.