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

Last updated: August 27, 2020
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Nasal Obstruction

Common Cold

Allergy

Treatment

N/A

Clinical Study ID

NCT04534452
18146
  • Ages 18-60
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female volunteers must be 18 to 60 years old.

  • Subjects must currently use or have previously used oral decongestant products.

  • Subjects must have a documented and/or self-reported history (of at least 2 years) ofallergic rhinitis with nasal congestion.

  • Subjects must be willing to stop use of current decongestant and allergy medicationsduring the study, and for the number of wash-out days required for their medicationprior to the run-in period.

  • Subjects must have nasal congestion due to allergic rhinitis of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) at Visits 1and 2.

  • Subjects must have a mean seated (after 5 minutes of rest) systolic/diastolic bloodpressure ≤ 138/88 mmHg.

  • Subjects must have normal or clinically acceptable physical exam.

  • Subjects must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days beforestudy participation and 14 days after the end of the study.

  • Subjects must be willing to give written informed consent (prior to any study relatedprocedures being performed) and able to adhere to restrictions and examinationschedules.

  • Female subjects of childbearing potential (a non-menopausal female who has not had ahysterectomy, bilateral oophorectomy, or medically documented ovarian failure,including a young woman who has not yet started menstruating) must be using medicallyacceptable (documented failure rate of less than 1%) birth control measures. Examplesof medically acceptable contraception include hormonal contraceptives, intrauterinedevice (IUD), double-barrier method (any combination of male or female condom,diaphragm, spermicidal gel, sponge) or sterilization.

Exclusion

Exclusion Criteria:

  • Subjects must not have any significant medical condition which, in the judgment of theinvestigator, is a contraindication to the use of phenylephrine HCl, might interferewith the study or requires treatment expected to affect the blood pressure. These mayinclude thyroid disease (e.g. hyperthyroidism, hypothyroidism), uncontrolled diabetesmellitus, coronary heart disease, ischemic heart disease, elevated intraocularpressure, prostatic hypertrophy, etc.

  • Subjects that have received allergen immunotherapy (if less than 3 months of stabledosing prior to screening) or Xolair (omalizumab) therapy within the past two years.

  • Subjects who have a history of any clinically significant local or systemic infectiousdisease within four weeks prior to treatment administration.

  • Subjects who have participated in a clinical trial of an investigational treatmentwithin 30 days prior to the start of the study.

  • Subjects who are, appear to be, or are known to be, current or former addicts oralcoholics.

  • Subjects who have a known allergy or intolerance to phenylephrine HCl or any otherdecongestant, or any antihistamine.

  • Females who are pregnant, nursing or unwilling to use/practice medically acceptablecontraception (documented failure rate of less than 1%).

  • Subjects who have used a nasal decongestant or phenylephrine-containing product otherthan study medication after the start of the study and during the washout period.

  • Subjects with a history of asthma, rhinitis medicamentosa, or presenting with acute orchronic sinusitis.

  • Subjects that have used inhaled, oral, rectal, topical (intranasal corticosteroids forallergic rhinitis are permitted), intramuscular, and/or intravenous chronic orintermittent corticosteroids (up to 1% topical hydrocortisone is permitted).

  • Subject who have family or who currently or previously have been employed in thepharmaceutical industry.

Study Design

Total Participants: 347
Study Start date:
May 12, 2012
Estimated Completion Date:
June 06, 2012

Connect with a study center

  • Allergy & Asthma Specialists, PC

    Blue Bell, Pennsylvania 19422
    United States

    Site Not Available

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