A Comparison of Three Medications to Treat Diarrhea in Adults.

NCT00807326 ↗

Phase 4 Completed 415 enrolled McNeil AB

RandomizedParallel-groupSingle-blindTreatment

Summary

A comparison of three medications to treat diarrhea in adults.

Timeline

Start: 2008-11
Primary completion: 2009-08
Completion: 2009-11

Outcome

Met primary endpoint

paper With regards to mean NUS 0-24, the loperamide-simeticone caplet was non-inferior to loperamide-simeticone tablets (3.4 vs. 3.3; one-sided 97.5 % confidence interval ≤0.5) PMID 26541878 ↗

paper both significantly lower than S. boulardii (4.3; p < 0.001). PMID 26541878 ↗

Publications

Cottrell J, Koenig K, Perfekt R, Hofmann R; Loperamide-Simethicone Acute Diarrhoea Study Team. Comparison of Two Forms of Loperamide-Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial. Drugs R D. 2015 Dec;15(4):363-73. doi: 10.1007/s40268-015-0111-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loperamide	Small molecule	2 mg	Oral
Comparator	Saccharomyces boulardii	Other / unclassified	250 mg	Oral
Subject	simeticone	Unknown	125 mg	Oral