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Scopolamine nasal spray in motion sickness: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo.

Author(s): Klocker N, Hanschke W, Toussaint S, Verse T

Affiliation(s): AUDIT Institute for Medical Services and Quality Assurance, Muhlfeldstr. 22, 65232, Taunusstein, Germany. audit.institute@t-online.de

Publication date & source: 2001-05, Eur J Pharm Sci., 13(2):227-32.

Publication type: Clinical Trial; Randomized Controlled Trial

Scopolamine has been used successfully for treatment of motion sickness for almost a century and the nasal administration was first studied 50 years ago. However, there never appeared a nasal dosage form. Finally, after finding a stable and suitable formulation for scopolamine, a study to investigate efficacy, safety, and tolerability was conducted, with a randomised, double-blind, double-dummy, crossover, Latin square design including placebo control and a placebo/placebo control for internal validity at the German Air Force Institute of Aviation Medicine. To assess the efficacy of a new, stable and well-tolerated formulation of scopolamine nasal spray the reproducible induction of whole body vibrations by a rotating chair was chosen and a validated seasickness score (SKS). The reduction of SKS showed that scopolamine nasal spray at a concentration of 0.2% was statistically superior to both placebo and dimenhydrinate (P=0.003 and 0.004, respectively). There were no signs for a nasal or epipharyngeal irritation of the mucous membrane. Scopolamine nasal spray was found to be an effective and safe treatment in motion sickness, with a fast onset of action within 30 min after administration.

Page last updated: 2006-01-31

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