check_circleStudy Completed
Nasal congestion due to allergic rhinitis
Bayer Identifier:
18146
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride extended release tablets after receiving it once in this study
Trial purpose
The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without special rate controlling) was already approved to be used for adults and children and the recommended dose for adults and children 12 years or older is 10mg every 4 hours. Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want to find out if participants have any medical problems during the trial.
Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.
Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.
Key Participants Requirements
Sex
AllAge
18 - 60 YearsTrial summary
Enrollment Goal
347Trial Dates
May 2012 - June 2012Phase
Phase 3Could I Receive a placebo
NoProducts
Sinus Comfort™ (Phenylephrine HCl, BAY112476)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Allergy & Asthma Specialists, PC | Blue Bell, 19422, United States |
Primary Outcome
- Purchase intent evaluated by using the 5-point scale• 4 = Very Acceptable • 3 = Acceptable • 2 = Somewhat acceptable • 1 = Somewhat unacceptable • 0 = Very unacceptabledate_rangeTime Frame:At approximately 8 hours postdose
Secondary Outcome
- Overall satisfaction for nasal congestion relief evaluated by using the 5-point scale• 4 = Very Acceptable • 3 = Acceptable • 2 = Somewhat acceptable • 1 = Somewhat unacceptable • 0 = Very unacceptabledate_rangeTime Frame:At approximately 8 hours postdose
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1