Journal of Neurogastroenterology and Motility : eISSN 2093-0887 / pISSN 2093-0879

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 0.297a
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
© J Neurogastroenterol Motil