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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: Completed Phase 3 study of Nasal Congestion Due to Allergic Rhinitis, sponsored by Bayer.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* 4 = Very Acceptable * 3 = Acceptable * 2 = Somewhat acceptable * 1 = Somewhat unacceptable * 0 = Very unacceptable
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 |
What the finished NCT04534452 record still lists
NCT04534452 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534452's enrollment target sits among peer trials
347 1048th of 2000 higher than 952 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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