Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
Phase 3
Completed
- Conditions
- Common Cold
- Registration Number
- NCT00452270
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction and duration of relief of nasal obstruction
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Cardiff, Wales, United Kingdom