Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 26, 2007
CompletedFirst Posted
Study publicly available on registry
March 27, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMay 3, 2007
May 1, 2007
March 26, 2007
May 2, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
and duration of relief of nasal obstruction
Interventions
Eligibility Criteria
You may qualify if:
- Over 18 years
- Have had moderate common cold symptoms for less than 36 hours.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Investigative Site
Cardiff, Wales, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis Investigative Site, Cardiff, Wales, UK
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2007
First Posted
March 27, 2007
Study Start
March 1, 2007
Study Completion
April 1, 2007
Last Updated
May 3, 2007
Record last verified: 2007-05