Original Contribution | Published:

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

Subjects

Abstract

OBJECTIVES:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1.

    , . Chronic constipation. N Engl J Med 2003;349:1360–1368.

  2. 2.

    American Gastroenterological Association Medical Position Statement: Guidelines on Constipation. Gastroenterology 2000;119:1761–1778.

  3. 3.

    AGA Technical Review on Constipation. Gastroenterology 2000;119:1766–1778.

  4. 4.

    . Management of chronic constipation. Rev Gastroenterol Disord 2004;4:18–24.

  5. 5.

    . Review article: The therapy of constipation. Aliment Pharmacol Ther 2001;15:749–763.

  6. 6.

    . Current treatment options for chronic constipation. Rev Gastroenterol Disord 2004;4:S34–S42.

  7. 7.

    , , , et al. Effect of tegaserod in chronic constipation: A randomized, double-blind, controlled trial. Clin Gastroenterol Hep 2004;2:796–805.

  8. 8.

    , , , et al. Tegaserod for the treatment of chronic constipation: A randomized, double-blind, placebo-controlled multinational study. Am J Gastroenterol 2005;100:362–372.

  9. 9.

    Lubiprostone (Amitiza) for chronic constipation. Med Lett Drugs Ther 2006;48:47–48.

  10. 10.

    , , , et al. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol 2000;95:446–450.

  11. 11.

    , . A meta-analysis of the clinical efficacy and safety of a new class of laxatives containing high molecular weight polyethylene glycol in patients with chronic constipation. Gastroenterology 2004;126:A640.

  12. 12.

    , , , et al. Report of an international workshop on management of constipation. Gastroenterol Int 1991;4:99–113.

  13. 13.

    , , , et al. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology 1980; 78:991–995.

  14. 14.

    , , . A low-sodium solution for gastrointestinal lavage. Gastroenterology 1990; 98:11–16.

  15. 15.

    , , , et al. Studies of osmotic diarrhea induced in normal subjects by ingestion of polyethylene glycol and lactulose. J Clin Invest 1989;84:1056–1062.

Download references

Acknowledgements

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

Affiliations

  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

Authors

  1. Search for Jack A DiPalma in:

  2. Search for Mark vB Cleveland in:

  3. Search for John McGowan in:

  4. Search for Jorge L Herrera in:

Corresponding author

Correspondence to Jack A DiPalma.

About this article

Publication history

Received

Accepted

Published

DOI

https://doi.org/10.1111/j.1572-0241.2007.01199.x