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NCT04534452 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Nasal Congestion Due to Allergic Rhinitis, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 347
- Enrollment target
- 1
- Study location
NCT04534452 is a Phase 3 study of Nasal Congestion Due to Allergic Rhinitis that has completed, run by Bayer. The registered enrollment target is 347 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04534452, a Phase 3 study of Nasal Congestion Due to Allergic Rhinitis, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 347 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Phenylephrine HCl (Sinus Comfort, BAY112476)
Study Locations (1)
Pennsylvania
- Allergy & Asthma Specialists, PC - Blue Bell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2012-05-12 |
| Est. Completion | 2012-06-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04534452
The ClinicalTrials.gov registry entry for NCT04534452 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 347 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nasal Congestion Due to Allergic Rhinitis appearing as the primary indexed condition, and to 1 intervention - of which Phenylephrine HCl (Sinus Comfort, BAY112476) is the first listed.
NCT04534452 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04534452 about?
NCT04534452 is a clinical study titled "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". 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...
What is the current status of trial NCT04534452?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 347 participants. The study started on 2012-05-12. Estimated completion is 2012-06-06.
What conditions does trial NCT04534452 study?
This clinical trial studies the following conditions: Nasal Congestion Due to Allergic Rhinitis.
What interventions are being tested in trial NCT04534452?
The interventions under investigation include: Phenylephrine HCl (Sinus Comfort, BAY112476) (DRUG).
Who is sponsoring clinical trial NCT04534452?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04534452 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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