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Functional Gi

A Randomized, Multicenter, Placebo-Controlled Trial of Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation

The American Journal of Gastroenterology volume 102, pages 14361441 (2007) | Download Citation




Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.


Study subjects who met defined criteria for chronic constipation were randomized in this double-blind, placebo-controlled, parallel, multicenter study to receive PEG laxative as a single daily dose of 17 g or placebo for 6 months. Baseline constipation status was confirmed during a 14-day observation period. As a primary efficacy variable, treatment success was defined as relief of modified ROME criteria for constipation for 50% or more of their treatment weeks. Various secondary measures were assessed. An Interactive Voice Response System (IVRS) recorded daily bowel movement experience and study efficacy and safety information. Laboratory testing at baseline and monthly for the study duration was analyzed for hematology, blood chemistry including amylase, GGT, uric acid, lipids, and urinalysis.


A total of 304 patients were enrolled and received treatment at one of 50 centers. Successful treatment according to the primary efficacy variable was seen in 52.0% of PEG and 11% of placebo subjects (P < 0.001). Similar efficacy was seen in a subgroup of 75 elderly subjects. According to the primary efficacy definition (based on individual treatment weeks), 61% of PEG treatment weeks versus 22% of the placebo weeks were successful (P < 0.001). There were no significant differences in laboratory findings or adverse events except for the gastrointestinal category where diarrhea, flatulence, and nausea were the most frequent with PEG although they were not individually statistically significant compared with placebo. Similar results were observed when analyzed for differences due to gender, race, or age.


PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.

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The authors thank the following investigators for their involvement in conducting this study:

Greg Anderson, M.D., Gastroenterology Research of Greater Cincinnati, Cincinnati

Charles F. Barish, M.D., Wake Research Associates, LLC, Raleigh

Daniel Brune, M.D., nTouch Research, Peoria

Antonio Caos, M.D., Central Florida Clinical Studies, Inc., Ocoee

Christopher Chappel, M.D., FPA Clinical Research, Kissimmee

David C. Chua, M.D., Summit Center of Clinical Research, Oakbrook Terrace

Teresa Coats, M.D., Benchmark Research, Austin

Barry Collins, M.D., Advanced Clinical Research, LLC, Pell City

Michael Collins, M.D., Clinical Research Consultants, Inc., Hoover

Richard Craven, M.D., East Coast Clinical Research, LLC, Virginia Beach

Adnan Dahdul, M.D., FutureCare Studies, Inc., Springfield

Steven G. Desautels, M.D., Mountain West Gastroenterology, Salt Lake City

Scott Becker, M.D., Austin Gastroenterology, PA, Austin

W. Travis Ellison, M.D., Radiant Research, Greer

Jack S. Faintuch, M.D., Radiant Research, Lake Worth

R. David Ferrera, M.D., Sacramento Research Medical Group, Sacramento

Chester L. Fisher, M.D., Health Research of Hampton Roads, Inc., Newport News

Elizabeth M. Gallup, M.D., JD, MBA, and Monica Pierson, M.D., Radiant Research, Kansas City, Overland Park

Mark Gotfried, M.D., PACT, Glendale

Jorge L. Herrera, M.D., University of South Alabama, Mobile

Darrell T. Herrington, D.O., Benchmark Research, San Angelo

John A. Hoekstra, M.D., Ph.D., National Clinical Research, Richmond

Walter Hood, M.D. and Stephen Gordon, M.D., Comprehensive NeuroScience, Inc., Atlanta

Marvin Lawrence, M.D., Maryland Digestive Disease Research, LLC, Laurel

Samuel Lederman, M.D., Radiant Research, Inc., West Palm Beach

Michael Levine, M.D., Radiant Research, Marietta

Margarita Nunez, M.D., Comprehensive NeuroScience, Inc., St. Petersburg

Jenny Liu, M.D., and Jeffrey Kaladas, M.D., Urgentmed, P.C., South Bound Brook

Barry Lubin, M.D., Hampton Roads Center for Clinical Research, Norfolk

F. Timm McCarty, D.O., Radiant Research, Scottsdale

John McNerney, M.D., Tucson Gastroenterology Specialists, Tucson

Mitchell D. Meyer, M.D., Wilmington Health Associates, Wilmington

David J. Morin, M.D., Tricities Medical Research, Bristol

Michael Noss, M.D., Radiant Research, Cincinnati

Peter M. Pardoll, M.D. and Sheldon Sheinert, M.D., Center for Digestive Diseases, St. Petersburg

Peter B. Platzer, M.D., Holston Medical Group, Kingsport

Patricia Reiff, M.D., Radiant Research, Phoenix

Dennis Riff, M.D., Advanced Clinical Research Institute, Anaheim

John Rubino, M.D., Multi-Specialty Research Association of North Carolina, Raleigh

Douglas Schumacher, M.D., Radiant Research, Columbus

William Seger, M.D., Benchmark Research, Fort Worth

Marc Shepard, M.D., nTouch Research, Washington

Timothy Smith, M.D., Mercy Health Research, St. Louis

Jonathan Simon Staub, M.D., Wilmington Health Associates, Wilmington

Miguel Trevino, M.D., Innovative Research of West Florida, Inc, Largo

Lawrence Wruble, M.D., Memphis Gastroenterology Group, Memphis

Thomas D. Bianchi, M.D., Community Medical Plaza, Tallassee

Author information


  1. Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, Alabama and Braintree Laboratories, Inc., Braintree, Massachusetts

    • Jack A DiPalma
    • , Mark vB Cleveland
    • , John McGowan
    •  & Jorge L Herrera


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Correspondence to Jack A DiPalma.

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