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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00452270
First received: March 26, 2007
Last updated: May 2, 2007
Last verified: May 2007

March 26, 2007
May 2, 2007
March 2007
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00452270 on ClinicalTrials.gov Archive Site
  • To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
  • and duration of relief of nasal obstruction
Same as current
Not Provided
Not Provided
 
Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Common Cold
Drug: Xylometazoline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2007
Not Provided

Inclusion Criteria:

  • Over 18 years
  • Have had moderate common cold symptoms for less than 36 hours.

Exclusion Criteria:

  • Congested/runny nose for more than two continuous weeks in the previous 12 months
  • Deviated septum or nasal polyps
  • Recent use of antibiotics
  • Recent sinusitis

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00452270
OTCS-CE-301
No
Not Provided
Novartis
Not Provided
Principal Investigator: Novartis Investigative Site, Cardiff, Wales, UK
Novartis
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP