National Cooperative Gallstone Study: Procedures Manual, Memoranda, and Study Forms

摘要

The report presents the revised clinical study procedures manual to be used with protocol for a randomized, double-blind, 3 treatment group trial to study the efficacy and safety of chenodeoxycholic acid in dissolving cholesterol gallstones. This treatment covers a two year period in gallstone patients of both sexes, all races, and ages 21 through 79. Treatment groups are: (1) placebo, (2) 375 mg/day chenodeoxycholic acid and (3) 750 mg/day chenodeoxycholic acid. It provides all instructions and reporting forms to be used in conforming to protocol.