Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. May 6, 2016; 7(2): 274-282
Published online May 6, 2016. doi: 10.4292/wjgpt.v7.i2.274
Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial
Thomas McGraw
Thomas McGraw, Thomas McGraw, Merck & Co., Inc., Kenilworth, NJ 07033, United States
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 non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Thomas McGraw, PhD, Thomas McGraw, Merck & Co., Inc., Kenilworth, 2000 Galloping Hill Road Kenilworth, NJ 07033, United States. thomas_p_mcgraw@yahoo.com
Telephone: +1-908-6044202
Received: October 29, 2015
Peer-review started: October 29, 2015
First decision: December 11, 2015
Revised: December 23, 2015
Accepted: January 9, 2016
Article in press: January 13, 2016
Published online: May 6, 2016
Processing time: 176 Days and 5.7 Hours
Abstract

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, cramping, 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 to AEs were reported. This trial is registered at clinicaltrials.gov as NCT00770432.

CONCLUSION: Oral administration of 17 g PEG 3350 once daily for a week is effective, safe, and well tolerated in subjects with occasional constipation.

Keywords: Polyethylene glycol 3350, Laxative, Straining, Bowel movements, Occasional constipation

Core tip: Unlike chronic constipation, which typically needs to be diagnosed by a healthcare professional, occasional constipation is a self-diagnosed condition. polyethylene glycol (PEG) 3350 (MiraLAX®) is a Food and Drug Administration-approved, once-daily oral over-the-counter laxative indicated for short-term (1 wk) use to relieve occasional constipation. However, very few data are available on the effectiveness of PEG 3350 for the treatment of occasional constipation. This is the first placebo-controlled study to evaluate the effectiveness and safety of PEG 3350 in subjects with occasional constipation after a week’s treatment.