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
Core Tip

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.