Journal of Neurogastroenterology and Motility

Table. 2. Table 2

Change in Colonic Transit Time by Treatment Assignment and Diagnosis, Modified Intention-to-Treat Population

Diagnosis group	Treatment assignment			P-value

	Placebo	Carboxymethylcellulose	CSP01
Overall (min)	(n = 8)	(n = 11)	(n = 19)
Change in CTT	+367	+15	–727	0.297^a
Baseline CTT	3088 ± 2083	3524 ± 2792	3288 ± 1838
On treatment CTT	3455 ± 2227	3539 ± 2841	2560 ± 1505
CIC (min)	(n = 4)	(n = 9)	(n = 13)
Change in CTT	+1113	–97	–263	0.025 (CSP01 vs placebo)^b
Baseline CTT	3193 ± 1728	3044 ± 2816	3334 ± 1963	0.117 (CMC vs placebo)^b
On treatment CTT	4306 ± 2717	2611 ± 2146	2254 ± 1235
IBS-C (min)	(n = 4)	(n = 2)	(n = 6)
Change in CTT	–92	+2035	+35	0.712 (CSP01 vs placebo)^c
Baseline CTT	2984 ± 2665	5684 ± 1757	3189 ± 1701	0.103 (CMC vs placebo)^c
On treatment CTT	2604 ± 2125	7719 ± 1085	3224 ± 1929

^aP-value obtained from a mixed between subject and within subject repeated measures analysis of covariance (ANCOVA) including treatment group, diagnosis (chronic idiopathic constipation [CIC] or irritable bowel syndrome with constipation [IBS-C]), gender, and age. The within subject factor crossed with each of the above was a 2-level Time factor (7 days pre-treatment or Day 15 of treatment).

^bPost hoc analysis using above ANCOVA model specifically among subsets of patients with CIC.

^cPost hoc analysis using above ANCOVA model specifically among subsets of patients with IBS-C.

Data are presented as mean ± SD.

J Neurogastroenterol Motil 2020;26:496~504 https://doi.org/10.5056/jnm20001