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

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ClinicalTrials.gov Identifier: NCT00452270
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : May 3, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Common Cold Drug: Xylometazoline Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  1. To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
  2. and duration of relief of nasal obstruction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452270


Locations
United Kingdom
Novartis Investigative Site
Cardiff, Wales, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative Site, Cardiff, Wales, UK

ClinicalTrials.gov Identifier: NCT00452270     History of Changes
Other Study ID Numbers: OTCS-CE-301
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007

Keywords provided by Novartis:
Common cold, xylometazoline

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Nasal Decongestants
Pseudoephedrine
Xylometazoline
Ephedrine
Vasoconstrictor Agents
Respiratory System Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents