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A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative.
Am J Gastroenterol. 2000 Feb; 95(2):446-50.AJ

Abstract

OBJECTIVE

This study was designed to determine the efficacy and safety of a new laxative, Braintree polyethylene glycol (PEG) laxative (Miralax, Braintree Laboratories, Braintree, MA).

METHODS

This investigation was designed as a placebo-controlled, blinded, randomized, multicenter parallel trial. Study subjects were constipated but otherwise healthy outpatients who had < or =2 stools during a 7-day qualification period. Braintree PEG laxative 17 g or dextrose placebo p.o. in 8 oz of water for a 14-day treatment period. A diary recorded each bowel movement and subjective symptoms of stool consistency, ease of passage, cramps, and flatus. CBC, blood chemistries and urinalysis were performed before and after the treatment period.

RESULTS

There were 151 randomized subjects, 131 female and 20 male. An increase in bowel movement frequency was observed with the PEG laxative as compared to placebo (p<0.001), with the greatest difference in efficacy in wk 2 of treatment (p<0.001). By wk 2 of treatment, on average, placebo subjects had 2.7 bowel movements/wk and PEG-treated study subjects had 4.5 movements/wk (p<0.01), or more than one bowel movement every 2 days. Investigator (p<0.005) and patient (p<0.001) subjective assessment of perception of treatment effectiveness, and patient evaluations of stool consistency and passage showed significant improvement in the active treatment group (p<0.001). There were no significant differences in laboratory changes or adverse experiences recorded between groups.

CONCLUSION

Braintree PEG laxative is safe and effective in the short term for the treatment of constipation.

Authors+Show Affiliations

Division of Gastroenterology, University of South Alabama College of Medicine, Mobile 36693, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10685748

Citation

DiPalma, J A., et al. "A Randomized, Placebo-controlled, Multicenter Study of the Safety and Efficacy of a New Polyethylene Glycol Laxative." The American Journal of Gastroenterology, vol. 95, no. 2, 2000, pp. 446-50.
DiPalma JA, DeRidder PH, Orlando RC, et al. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95(2):446-50.
DiPalma, J. A., DeRidder, P. H., Orlando, R. C., Kolts, B. E., & Cleveland, M. B. (2000). A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. The American Journal of Gastroenterology, 95(2), 446-50.
DiPalma JA, et al. A Randomized, Placebo-controlled, Multicenter Study of the Safety and Efficacy of a New Polyethylene Glycol Laxative. Am J Gastroenterol. 2000;95(2):446-50. PubMed PMID: 10685748.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. AU - DiPalma,J A, AU - DeRidder,P H, AU - Orlando,R C, AU - Kolts,B E, AU - Cleveland,M B, PY - 2000/2/24/pubmed PY - 2000/3/11/medline PY - 2000/2/24/entrez SP - 446 EP - 50 JF - The American journal of gastroenterology JO - Am J Gastroenterol VL - 95 IS - 2 N2 - OBJECTIVE: This study was designed to determine the efficacy and safety of a new laxative, Braintree polyethylene glycol (PEG) laxative (Miralax, Braintree Laboratories, Braintree, MA). METHODS: This investigation was designed as a placebo-controlled, blinded, randomized, multicenter parallel trial. Study subjects were constipated but otherwise healthy outpatients who had < or =2 stools during a 7-day qualification period. Braintree PEG laxative 17 g or dextrose placebo p.o. in 8 oz of water for a 14-day treatment period. A diary recorded each bowel movement and subjective symptoms of stool consistency, ease of passage, cramps, and flatus. CBC, blood chemistries and urinalysis were performed before and after the treatment period. RESULTS: There were 151 randomized subjects, 131 female and 20 male. An increase in bowel movement frequency was observed with the PEG laxative as compared to placebo (p<0.001), with the greatest difference in efficacy in wk 2 of treatment (p<0.001). By wk 2 of treatment, on average, placebo subjects had 2.7 bowel movements/wk and PEG-treated study subjects had 4.5 movements/wk (p<0.01), or more than one bowel movement every 2 days. Investigator (p<0.005) and patient (p<0.001) subjective assessment of perception of treatment effectiveness, and patient evaluations of stool consistency and passage showed significant improvement in the active treatment group (p<0.001). There were no significant differences in laboratory changes or adverse experiences recorded between groups. CONCLUSION: Braintree PEG laxative is safe and effective in the short term for the treatment of constipation. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/10685748/A_randomized_placebo_controlled_multicenter_study_of_the_safety_and_efficacy_of_a_new_polyethylene_glycol_laxative_ L2 - https://Insights.ovid.com/pubmed?pmid=10685748 DB - PRIME DP - Unbound Medicine ER -