FreshBurst Listerine protocol
This article was originally published in The Tan Sheet
Executive Summary
Pfizer proposes six-month, multi-center gingivitis study of 340 subjects at three clinical sites in Canada, Florida and Ohio for FreshBurst Listerine with Fluoride in Oct. 14 letter to FDA. Each center will have a principal investigator, who also may function as the site's clinical examiner. Pfizer originally had suggested a single-center study, which FDA opposed at an Aug. 27 feedback meeting (1"The Tan Sheet" Sept. 2, 2002, p. 14). Pfizer also agrees with FDA's suggestion to reduce the number of exclusion criteria. Pregnant women, diabetics, individuals with partial dentures or oral piercings are included under modified protocol, while those with "history of significant adverse events following use of oral hygiene products," "history of serious medical conditions" or alcoholism are excluded...