Clinical Trial: Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study, Evaluating the Decongestant Effect, Time to Onset, Duration of Effect and Impact on Sleep and General Well-Being of Xylometazoline

Brief Summary: The aim of this study is to characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome:

  • To evaluate the decongestant effect of xylometazoline in subjects with
  • common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
  • and duration of relief of nasal obstruction


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: March 26, 2007
Date Started: March 2007
Date Completion:
Last Updated: May 2, 2007
Last Verified: May 2007