Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
This study has been completed.
Information provided by:
First received: March 26, 2007
Last updated: May 2, 2007
Last verified: May 2007
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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 in Subjects With a Common Cold|
Resource links provided by NLM:
Drug Information available for: Ephedrine Hydrochloride Pseudoephedrine Ephedrine sulfate Pseudoephedrine hydrochloride Xylometazoline Xylometazoline hydrochloride Pseudoephedrine sulfateU.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
- and duration of relief of nasal obstruction
|Study Start Date:||March 2007|
|Study Completion Date:||April 2007|
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