check_circleStudy Completed

Nasal congestion due to allergic rhinitis

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.

Key Participants Requirements

Sex

All

Age

18 - 60 Years

Trial summary

Enrollment Goal
347
Trial Dates
May 2012 - June 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Sinus Comfort™ (Phenylephrine HCl, BAY112476)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Allergy & Asthma Specialists, PCBlue 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 unacceptable
    date_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 unacceptable
    date_rangeTime Frame:
    At approximately 8 hours postdose

Trial design

A Multicenter, Consumer Product Evaluation of a Single Dose of Phenylephrine Hydrochloride 30 mg Extended Release Tablets (Sinus Comfort™)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1