Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints

Table 1

Demographics and baseline characteristics.

Outcome	PEG 3350 (n = 204)	Placebo (n = 100)	P value^†
Age, mean (SD)	53.1 (14.9)	54.4 (15.0)	0.46
Sex, n (%)
Female	175 (86)	83 (83)
Male	29 (14)	17 (17)	0.56
Weight, mean (SD), kg	74.7 (16.3)	75.1 (15.6)	0.65
Duration of constipation, mean (SD)	23.4 (18.7)	22.6 (19.2)	0.66
Baseline^a CSBM/week, mean (SD)
Week −2	0.7 (1.14)	0.6 (0.99)
Week −1	0.8 (1.14)	0.9 (3.76)
Baseline^a SBM/week, mean (SD)
Week −2	3.2 (3.26)	3.4 (3.64)
Week −1	2.9 (3.23)	4.0 (7.31)

Abbreviations: CSBM, complete spontaneous bowel movement; PEG, polyethylene glycol; SBM, spontaneous bowel movement; SD, standard deviation ^∗P < 0.05 (a) Fourteen-day pretreatment observation period ^†should be P < 0.05.