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NCT00452270 Clinical Trial

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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452270
Other study ID # OTCS-CE-301
Secondary ID
Status Completed
Phase Phase 3
First received March 26, 2007
Last updated May 2, 2007
Start date March 2007
Est. completion date April 2007

Study information
Verified date May 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Xylometazoline

Locations
Country Name City State
United Kingdom Novartis Investigative Site Cardiff Wales

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the decongestant effect of xylometazoline in subjects with
Primary common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.
Secondary To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
Secondary and duration of relief of nasal obstruction
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