Back to resultsDecongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Xylometazoline
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Common cold, xylometazoline
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452270
Brief Title
Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
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 Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Common cold, xylometazoline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Xylometazoline
Primary Outcome Measure Information:
Title
To evaluate the decongestant effect of xylometazoline in subjects with
Title
common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.
Secondary Outcome Measure Information:
Title
To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
Title
and duration of relief of nasal obstruction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Investigative Site, Cardiff, Wales, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Cardiff
State/Province
Wales
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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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