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OpenTrials
Completed

NCT Number: NCT00452270

Decongestant Effect, Timing 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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Cardiff, Wales, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xylometazoline

Drug

Primary outcomes

  1. To evaluate the decongestant effect of xylometazoline in subjects with

  2. common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.

Secondary outcomes

  1. To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction

  2. and duration of relief of nasal obstruction

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2007
First posted
Mar 27, 2007
Registry last updated
May 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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