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.

First Received: March 26, 2007 Last Updated: May 2, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00452270

Purpose

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.

Condition	Intervention	Phase
Common Cold	Drug: Xylometazoline	Phase III

MedlinePlus related topics: Common Cold

Drug Information available for: Ephedrine Hydrochloride Phenylephrine Phenylephrine hydrochloride Ephedrine Pseudoephedrine hydrochloride Xylometazoline Xylometazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Pseudoephedrine Sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
and duration of relief of nasal obstruction

Estimated Enrollment:	60
Study Start Date:	March 2007
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452270

Locations

United Kingdom, Wales
Novartis Investigative Site
Cardiff, Wales, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Investigative Site, Cardiff, Wales, UK

Unaffiliated

More Information

No publications provided

Study ID Numbers:	OTCS-CE-301
Study First Received:	March 26, 2007
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00452270 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Common cold, xylometazoline

Study placed in the following topic categories:

Pseudoephedrine
Xylometazoline
Picornaviridae Infections
Cardiovascular Agents
Nasal Decongestants
Virus Diseases
Oxymetazoline

Respiratory Tract Infections
Respiratory Tract Diseases
Common Cold
Phenylephrine
Vasoconstrictor Agents
Ephedrine

Additional relevant MeSH terms:

Respiratory System Agents
RNA Virus Infections
Xylometazoline
Picornaviridae Infections
Cardiovascular Agents
Pharmacologic Actions
Nasal Decongestants

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Common Cold
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on May 07, 2009