Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial

Table 1 Patient demographics and baseline characteristics n (%)

Summary	Treatment group		All subjects	P value1
	PEG 3350	Placebo
ITT subjects	102	101	203
Gender				0.2165
Male	25 (24.5)	33 (32.7)	58 (28.6)
Female	77 (75.5)	68 (67.3)	145 (71.4)
Age (yr)				0.7361
n	102	101	203
Mean ± SD	45.8 ± 12.52	45 ± 14.15	45.4 ± 13.33
Race				0.3340
American Indian	0	2 (2.0)	2 (1.0)
Alaskan native	0	0	0
Asian	0	0	0
Black/African American	7 (6.9)	9 (8.9)	16 (7.9)
Native Hawaiian	0	0	0
White	81 (79.4)	71 (70.3)	152 (74.9)
Hispanic or Latino	14 (13.7)	19 (18.8)	33 (16.3)
Weight (kg)				0.5257
n	102	101	203
Mean ± SD	80.2 ± 19.11	79.7 ± 21.19	79.9 ± 20.12
On average, how many successful bowel movements does the subject have per week?				0.8232
0-2	36 (35.3)	35 (34.7)	71 (35.0)
3-5	44 (43.1)	40 (39.6)	84 (41.4)
6-8	22 (21.6)	25 (24.8)	47 (23.2)
> 9	0	1 (1.0)	1 (0.5)
What type of laxative is this?				0.6775
Stimulant	57 (55.9)	63 (62.4)	120 (59.1)
Bulk forming fiber	12 (11.8)	15 (14.9)	27 (13.3)
Lubricant	3 (2.9)	2 (2.0)	5 (2.5)
Osmotic	8 (7.8)	4 (4.0)	12 (5.9)
Carbon dioxide releasing	0	0	0
Stool softener	18 (17.6)	15 (14.9)	33 (16.3)
Combination	2 (2.0)	0	2 (1.0)
Other	2 (2.0)	2 (2.0)	4 (2.0)

¹Wilcoxon Rank-Sum test was used to assess homogeneity among treatment groups of baseline continuous variables, and Fisher’s exact test was used to evaluate categorical variables. ITT: Intent to treat; PEG: Polyethylene glycol.

Table 2 Summary of average daily diary bowel movement assessments of the subjects n (%)

Mean (SD)	Placebon = 94	PEG 3350n = 98	P value1
Average BMs per day	1.0 (0.63)	1.1 (0.84)	0.46
Average BMs per day that were complete without straining or lumpy stool	0.5 (0.46)	0.6 (0.46)	0.57
Percent of all BMs that were complete without straining or lumpy stool	18.4 (25.00)	34 (35.84)	0.0002
Percent of all BMs that were failures	10.2 (17.64)	10.1 (19.31)	0.94
Percent of all BMs that were incomplete	34.6 (27.75)	25.7 (28.49)	0.16

¹ANOVA controlling for site and site by treatment interaction was used to test homogeneity of response across treatment arms. BM: Bowel movement; ANOVA: Analysis of variance; PFG: Polyethylene glycol.

Table 3 Summary of global assessments n (%)

Summary	Treatment group		P value1
	PEG 3350	Placebo
Per-protocol subjects, n	98	94
It works better than other laxatives I have tried
Strongly agree	16 (16.3)	8 (8.5)	0.0037
Agree	34 (34.7)	27 (28.7)
Neither agree nor disagree	24 (24.5)	15 (16.0)
Disagree	19 (19.4)	35 (37.2)
Strongly disagree	5 (5.1)	9 (9.6)
Not applicable/missing	0	0
It is the best laxative I have tried
Strongly agree	18 (18.4)	7 (7.4)	0.0005
Agree	22 (22.4)	13 (13.8)
Neither agree nor disagree	26 (26.5)	22 (23.4)
Disagree	23 (23.5)	36 (38.3)
Strongly disagree	9 (9.2)	16 (17.0)
Not applicable/missing	0	0
It helps me feel less irritable
Strongly agree	6 (6.1)	7 (7.4)	0.0414
Agree	32 (32.7)	26 (27.7)
Neither agree nor disagree	38 (38.8)	25 (26.6)
Disagree	18 (18.4)	21 (22.3)
Strongly disagree	4 (4.1)	14 (14.9)
Not applicable/missing	0	1 (1.1)
It helps me feel more confident
Strongly agree	7 (7.1)	7 (7.4)	0.0262
Agree	25 (25.5)	15 (16.0)
Neither agree nor disagree	38 (38.8)	28 (29.8)
Disagree	19 (19.4)	28 (29.8)
Strongly disagree	8 (8.2)	14 (14.9)
Not applicable/missing	1 (1.0)	2 (2.1)
It feels better for my body than other laxatives I have tried
Strongly agree	13 (13.3)	8 (8.5)	0.0215
Agree	34 (34.7)	27 (28.7)
Neither agree nor disagree	24 (24.5)	15 (16.0)
Disagree	18 (18.4)	30 (31.9)
Strongly disagree	9 (9.2)	14 (14.9)
Not applicable/ missing	0	0

¹The P value obtained from Cochran-Mantel-Haenszel row mean scores difference χ² test adjusted for study site was used to compare homogeneity of results in treatment arms.

Table 4 Summary of treatment-emergent adverse events, safety population n (%)

Summary	Treatment group
	PEG 3350	Placebo
Total subjects	102	101
Total subjects with an adverse event	14 (13.7)	17 (16.8)
Nervous system disorders	11 (10.8)	11 (10.9)
Headache	11 (10.8)	11 (10.9)
Migraine	1 (< 1.0)	0
Musculoskeletal and connective tissue disorders	3 (2.9)	2 (2.0)
Back pain	0	2 (2.0)
Neck pain	2 (2.0)	0
Arthralgia	1 (< 1.0)	0
Gastrointestinal disorders	0	4 (4.0)
Nausea	0	2 (2.0)
Abdominal distension	0	1 (< 1.0)
Dyspepsia	0	1 (< 1.0)
Infections and infestations	1 (< 1.0)	1 (< 1.0)
Nasopharyngitis	1 (< 1.0)	0
Sinusitis	0	1 (< 1.0)
Psychiatric disorders	1 (< 1.0)	1 (< 1.0)
Insomnia	1 (< 1.0)	1 (< 1.0)
Respiratory, thoracic, and mediastinal disorders	2 (2.0)	0
Nasal congestion	1 (< 1.0)	0
Pharyngolaryngeal pain	1 (< 1.0)	0

PEG: Polyethylene glycol.

Table 5 List of study sites¹ and primary investigators

Site	Primary investigator
Product Investigations, Inc., Conshohocken, PA	Morris Shelanski, MD
Site 2, Turnpike Levittown, NY	Maurice Gunsberger, MD
Site 3, South Windsor, CT	Raymond Kurker, MD
International Research Services, Inc., Port Chester, NY	Roger A. Villi, MD
Hartford Research Center	Anthony Roselli, MD
Product Investigations, Inc., Modesto, CA	Clinton E. Prescott, MD
International Research Services, Inc, Rockland, ME	Robert Jorden, MD
Avon Family Medical Group, Avon, CT	Anthony Roselli, MD

¹Of the 8 participating sites, only 7 sites enrolled ≥ 1 subject.