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.
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.
Klöcker
N
N
AUDIT Institute for Medical Services and Quality Assurance, Mühlfeldstr. 22, 65232, Taunusstein, Germany. audit.institute@t-online.de
Hanschke
W
W
Toussaint
S
S
Verse
T
T
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004111:Dimenhydrinate / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009041:Motion Sickness / Q000188:drug therapy*; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D012601:Scopolamine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000932:Antiemetics; D018727:Muscarinic Antagonists; D012601:Scopolamine; D004111:Dimenhydrinate