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In Brief: NDMA attapulgite trial

This article was originally published in The Tan Sheet

Executive Summary

NDMA attapulgite trial: Enrollment in a study to compare the effectiveness of attapulgite and a placebo in the treatment of acute non-specific diarrhea is "well on the way" to reaching its goal of 230 subjects, the Nonprescription Drug Manufacturers Association told FDA on April 11. About 175 participants in Mexico and 100 in Jamaica have met all of the study's inclusion criteria. However, of those, only about 30% in Mexico and 25% in Jamaica were found to have pathogen-positive stools and thus will be evaluated, NDMA said. NDMA agreed to do the study at a 1995 "feedback" meeting. The association asked FDA in February 1995 to allow the continued marketing of attapulgite based on in vitro efficacy data ("The Tan Sheet" March 13, 1995, p. 13)...
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