Efficacy and safety of a novel sodium picosulfate oral tablet in a randomized controlled trial for bowel preparation

Table 1 Baseline characteristics of study participants (all randomized set), n (%)/mean ± SD

	Total (n = 215)	DWJ1609 group (n = 108)	Oral sulfate tablet group (n = 107)	P value
Age (years)	43.3 ± 10.94	42.8 ± 11.83	43.8 ± 10.00	0.5631
Age < 65 years	208 (96.74)	103 (95.37)	105 (98.13)	0.4452
Age ≥ 65 years	7 (3.26)	5 (4.63)	2 (1.87)
Sex
Men	78 (36.28)	36 (33.33)	42 (39.25)	0.3672
Women	137 (63.72)	72 (66.67)	65 (60.75)
Body mass index (kg/m2)	23.94 ± 3.1005	24.072 ± 3.1191	23.802 ± 3.0904	0.6611

¹Testing for between-group differences in continuous variables after normality assessment (two-sample t-test or Wilcoxon rank-sum test).

²Testing for between-group differences in categorical variables (χ² test or Fisher’s exact test, depending on expected cell counts).

Table 2 Bowel preparation efficacy based on the Harefield Cleansing Scale (per-protocol set 1), n (%)

	DWJ1609 group (n = 99)	Oral sulfate tablet group (n = 101)	P value1
Overall cleansing based on Harefield Cleansing Scale			0.164
Grade A	62 (62.63)	73 (72.28)	0.145
Grade B	34 (34.34)	28 (27.72)	0.316
Grade C	2 (2.02)	0 (0)	0.244
Grade D	1 (1.0)	0 (0)	0.495
Successful bowel cleansing (grade A/B) reader	96/99 (96.97)	101/101 (100.00)	0.119

¹Testing for between-group differences in categorical variables (χ² test or Fisher’s exact test, depending on expected cell counts).

Table 3 Adverse drug reactions of the DWJ1609 and oral sulfate tablet groups (safety analysis set), n (%)

	DWJ1609 group (n = 105)	Oral sulfate tablet group (n = 106)	P value1
Adverse drug reaction	19 (18.10)	35 (33.02)	0.013
Gastrointestinal disorders	16 (15.24)	27 (25.47)	0.065
Nausea	8 (7.62)	23 (21.70)	0.004
Vomiting	6 (5.71)	3 (2.83)	0.332
Abdominal distension	4 (3.81)	6 (5.66)	0.748
Diarrhea	1 (0.95)	0	0.498
Gastroesophageal reflux disease	1 (0.95)	0	0.498
Abdominal pain	0	1 (0.94)	1.000
Gastritis erosive	0	1 (0.94)	1.000
Nervous system disorders	3 (2.86)	12 (11.32)	0.017
Dizziness	2 (1.90)	5 (4.72)	0.445
Headache	1 (0.95)	9 (8.49)	0.019
Hypoaesthesia	0	1 (0.94)	1.000
General disorders and administration site conditions	0	2 (1.89)	0.498
Chest discomfort	0	1 (0.94)	1.000
Chills	0	1 (0.94)	1.000
Metabolism and nutrition disorders	0	1 (0.94)	1.000
Hyponatremia	0	1 (0.94)	1.000

¹Testing for between-group differences in categorical variables (χ² test or Fisher’s exact test, depending on expected cell counts).