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

Eur J Pharm Sci. 2001 May;13(2):227-32. doi: 10.1016/s0928-0987(01)00107-5.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Antiemetics / therapeutic use*
  • Cross-Over Studies
  • Dimenhydrinate / therapeutic use
  • Female
  • Humans
  • Male
  • Middle Aged
  • Motion Sickness / drug therapy*
  • Muscarinic Antagonists / adverse effects
  • Muscarinic Antagonists / therapeutic use
  • Scopolamine / adverse effects
  • Scopolamine / therapeutic use*
  • Treatment Outcome

Substances

  • Antiemetics
  • Muscarinic Antagonists
  • Scopolamine
  • Dimenhydrinate