A Randomized, Placebo-Controlled, Multicenter Study of The Safety and Efficacy of A New Polyethylene Glycol Laxative

DiPalma, Jack A.; DeRidder, Peter H.; Orlando, Roy C.; Kolts, Byron E.; Cleveland, Mark

doi:10.1111/j.1572-0241.2000.01765.x

Cited by 180 publications

(103 citation statements)

References 17 publications

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“…The current study demonstrated that in subjects with self-reported occasional constipation, there is no significant difference between PEG 3350 and placebo in achieving relief from straining and reduction in hardness of stools experienced during BMs. PEG 3350 was generally well tolerated; AEs were similar in incidence and severity (mostly mild) between treatment groups, in line with previous reports [19,[22][23][24][25][26] . The present study used the subject's own estimation of treatment effect to evaluate whether treatment with PEG 3350 led to resolution of straining and lumpy/hard stools compared with placebo.…”

Section: Discussionsupporting

confidence: 76%

“…Most subjects suffering from constipation are likely, at least initially, to use OTC laxatives for relieving their symptoms, and are generally not satisfied with the results [3,7,31] . PEG 3350 has been reported to be effective in relieving cramping and gas symptoms in subjects with chronic constipation [19,26] , yet other secondary measures evaluating the effect of PEG 3350 on cramping and gas showed no significant difference between PEG 3350 and placebo. This may be due to the fact that the beneficial effect of PEG relative to placebo is confined to improved stool consistency, which may be due to increased osmotic action of intraluminal content, and hence does not affect cramping and gas; it may also be due to the relatively milder symptoms of subjects with occasional constipation and the limited duration of treatment.…”

Section: Discussionmentioning

confidence: 99%

“…Preference questionnaires were presented as binary outcomes and analyzed using CMH and ANOVA. [27,28] , tegaserod [29] , prucalopride, lubiprostone, and linaclotide [30] , as well as PEG [19,[22][23][24][25] for the treatment of chronic constipation. However, there are no reports on the effectiveness of PEG 3350 for the treatment of occasional constipation.…”

Section: Discussionmentioning

confidence: 99%

“…PEG 3350 is effective in the treatment of constipation in adults, having been shown to significantly increase the frequency of BMs, improve the symptoms of constipation [22][23][24][25][26] , and reduce cramping and gas [19] . The Food and Drug Administration (FDA) approved PEG 3350 (MiraLAX ® ) on October 6, 2006 (NDA 22-015) for use as a nonprescription laxative for relief from occasional constipation (irregularity).…”

Section: Miralaxmentioning

confidence: 99%

“…Osmotic laxatives aid defecation by increasing the osmotic pressure in the lumen of the gastrointestinal tract. Osmotic laxatives are known to improve frequency, straining, and the form of stools [17][18][19] . PEG has been shown to be more effective than lactulose in the management of chronic constipation and exhibited lesser side effects than lactulose [15,16] .…”

Section: Introductionmentioning

confidence: 99%

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

McGraw

2016

WJGPT

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AIM: to evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in subjects with self-reported occasional constipation. METHODS:Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial. Evaluations were conducted before (baseline) and after a 7-d treatment period. The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools. Secondary efficacy variables assessed the severity of the subjects' daily bowel movement (BM) symptoms, and preference of laxatives based on diary entries, visual analog scale scores, and questionnaires. RESULTS:Of the 203 subjects enrolled in the study, 11 had major protocol violations. Complete resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94 (24.5%) in the placebo group (P = 0.0595). The number of complete BMs without straining or lumpy stools was similar between both groups. Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a 7-d period (P < 0.0001). Subjects reported that PEG 3350 had a better effect on their daily lives, provided better control over a BM, better relief from constipation, Author contributions: McGraw T contributed to the conception, design and planning of the study, data acquisition and analysis, interpretation of results, drafting the manuscript, and critically reviewing and revising the manuscript in terms of intellectual content.Institutional review board statement: The study was reviewed and supervised by Allendale IRB for all sites.Clinical trial registration: This study is registered at https:// clinicaltrials.gov/ct2/show/NCT00770432. The registration identification number is NCT00770432.Informed consent statement: Written informed consent was obtained from all subjects prior to any study-related procedures. Conflict-of-interest statement:McGraw T was an employee of Merck & Co., Inc., Kenilworth, NJ, United States when the study was conducted. Merck & Co. was involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Data sharing statement:No additional data are available.Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Randomized Clinical Trialcramping, and bloating, and was their preferred laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo groups. No deaths, serious AEs, or discontinuations due...

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