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The role of an initial single‐blind placebo period in phase I clinical trials *
Author(s) -
y P.,
Boissel JP,
Girard P.,
Lion L.,
Haugh MC,
Fareh S.,
Breyne B.
Publication year - 1994
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1111/j.1472-8206.1994.tb00796.x
Subject(s) - placebo , clinical trial , medicine , double blind , period (music) , single blind , latin square , surgery , randomized controlled trial , pathology , chemistry , rumen , physics , alternative medicine , food science , fermentation , acoustics
Summary— The effect of an initial single‐blind placebo period in a phase 1 clinical trial was assessed in 12 volunteers who underwent five weekly treatment periods, consisting of treatment on the first day and a six‐day wash‐out period. An initial single‐blind placebo period was followed by three different single doses of a platelet‐aggregation factor inhibitor and another placebo period, under a double‐blind Latin square design. Reports of abnormal symptoms were collected using a questionnaire designed by our group. A total of 13 abnormal symptoms were reported during the first period and only nine for the following four periods, indicating a clear placebo period effect. These preliminary results suggest that an initial single‐blind period may be usefully included in phase 1 clinical trials.