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

Novartis

Status and phase: Completed; Phase 3

Conditions: Common Cold

Treatments: Drug: Xylometazoline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452270

OTCS-CE-301

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind