A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold
Efficacy and Safety of an Antiviral Polymeric Nasal Spray: A Randomized, Parallel Group, Double-blind, Placebo-controlled Study in Subjects With Early Symptoms of Common Cold
2 other identifiers
interventional
163
1 country
3
Brief Summary
This study will test 200 people to see if an experimental nasal spray has an effect on symptoms of the common cold if used when the symptoms start. At the first visit to the clinic, potential subjects will have tests to make sure they qualify to participate in the study. If they qualify, they will have an equal chance of receiving the experimental nasal spray or a sham nasal spray (one that does not have the experimental formula). At the first visit, subjects will receive their assigned nasal spray and use it once at the clinic. They will also receive a booklet called a diary. Subjects will take the rest of their treatments for day 1 at home, and for the next six days, they will use the nasal spray four times per day and record their symptoms in the diary, as instructed. Then subjects will come back to the clinic for a final visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
3 active sites
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
First Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 9, 2012
May 1, 2012
4 months
December 6, 2011
May 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Symptoms of the Common Cold
Subjects will score their symptoms of the common cold including local symptoms (sore throat, blocked nose, runny nose, cough, and sneezing) and systemic symptoms (headache, muscle ache, and chilliness) on a scale of 0-3, where 0=: None (symptoms not present in the previous 24 hours) and 3= Severe (symptoms disturbing/irritating most of the time).
Within 7 days
Secondary Outcomes (4)
Effect of Common Cold on Daily Activities
Within 7 days
Effect of Common Cold Symptoms on Sleep
Within 7 days
Number of Days Lost
Within 7 days
Treatment Outcome
Within 7 days
Study Arms (2)
PNS
EXPERIMENTAL2 sprays of experimental nasal spray per nostril 4 times per day for 7 days
SNS
SHAM COMPARATOR2 sprays of sham nasal spray per nostril 4 times per day for 7 days
Interventions
Experimental nasal spray
Eligibility Criteria
You may qualify if:
- Have early signs of a common cold: If female of child-bearing potential, have a negative pregnancy test at Screening.
- Have signed and dated the informed consent document, indicating that they have been informed of all pertinent aspects of the investigation
- Are willing and able to comply with scheduled visits, treatment plan, and other investigation procedures
You may not qualify if:
- Have had common cold or flu-like symptoms outside the protocol-specified parameters.
- Are current smokers as defined by the protocol.
- Have any medical history or condition or use any drug or device that (per protocol or in the opinion of the investigator) might compromise subject safety, participation in the trial, action of the investigational device, or results of the investigation..
- Are related to anyone involved with the conduct of the investigation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (3)
Synexus Thames Valley
Reading, Berkshire, RG2 0TG, United Kingdom
Synexus Wales
Cardiff, Llaishen, CF14 5GJ, United Kingdom
Common Cold Center and Healthcare Clinical Trials
Cardiff, Wales, CF10 3AX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
McNeil AB
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 8, 2011
Study Start
January 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 9, 2012
Record last verified: 2012-05