Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
Condition: Vasomotor Rhinitis; Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Vasomotor
Intervention: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg; Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
Intervention description: Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.; Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, two-way crossover, multicenter study evaluating the consumer preference
      of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or
      Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in
      subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250
      participants will complete a questionnaire after taking one test product for 3 days followed
      by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days.
      Analysis of which product the consumer preferred, if any, and which product was more
      convenient, if any, will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female volunteers must be 18 years or older.

          -  Participants must be willing to stop use of current decongestant and allergy
             medications during the study, and at the start of the run-in period (Visit 2).

          -  Participants must have a documented history of allergic rhinitis caused by ragweed
             allergen for at least the prior two years.

          -  Participants must have a documented skin testing (prick with wheal >= 3 mm larger than
             the diluent or intradermal with wheal >=7 mm larger than the diluent control) or a
             positive in vitro test for specific IgE to the ragweed allergen within the last four
             years.

          -  Participants must have signs by clinical evaluation and symptoms of nasal congestion
             of at least mild severity (sign/symptom clearly present, but minimal awareness; easily
             tolerated) at Visit 3 following the run-in period and at visit 5 following the washout
             period.

          -  Clinical laboratory tests (complete hematology, blood chemistries, urinalysis) must be
             within normal limits or clinically acceptable to the Investigator/Sponsor. Sponsor
             will not grant waivers.

          -  Participants must have a seated (after 5 minutes of rest) systolic/diastolic blood
             pressure ≤ 138/88 mmHg.

          -  Participants must have normal or clinically acceptable physical exam and
             electrocardiogram (ECG) on 12-lead ECG (recorded at 25 mm/s).

          -  Participants must be free of any clinically significant disease that requires a
             physician's care and/or would interfere with study evaluations, procedures or
             participation.

          -  Participants must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days
             before study participation and 14 days after the end of the study.

          -  Participants must be willing to give written informed consent (prior to any study
             related procedures being performed) and able to adhere to restrictions and examination
             schedules.

          -  Female participants of childbearing potential (a non-menopausal female who has not had
             a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure,
             including a young woman who has not yet started menstruating) must be using medically
             acceptable (documented failure rate of less than 1%) birth control measures. Examples
             of medically acceptable contraception include hormonal contraceptives, intrauterine
             device (IUD), double-barrier method (any combination of male or female condom,
             diaphragm, spermicidal gel, sponge) or sterilization.

          -  Participants must be able to read and write English, and must understand the dosing
             schedule.

        Exclusion Criteria:

          -  Participants must not have any significant medical condition which, in the judgment of
             the investigator, is a contraindication to the use of phenylephrine HCl, might
             interfere with the study or requires treatment expected to affect the blood pressure.
             These may include thyroid disease (e.g. hyperthyroidism, hypothyroidism), uncontrolled
             diabetes mellitus, coronary heart disease, ischemic heart disease, elevated
             intraocular pressure, prostatic hypertrophy, etc.

          -  Participants that have received allergen immunotherapy or Xolair (omalizumab) therapy
             within the past two years.

          -  Participants who have a history of any clinically significant local or systemic
             infectious disease within four weeks prior to initial treatment administration.

          -  Participants who have participated in a clinical trial of an investigational treatment
             within 30 days prior to the start of the study (Run-in Period Day 1).

          -  Participants who are, appear to be, or are known to be, current or former addicts or
             alcoholics.

          -  Participants who have a known allergy or intolerance to phenylephrine HCl, any other
             decongestant, loratadine, desloratadine or any other antihistamine.

          -  Females who are pregnant, nursing or unwilling to use/practice medically acceptable
             contraception (documented failure rate of less than 1%).

          -  Participants with a history of asthma, rhinitis medicamentosa, or acute or chronic
             sinusitis.

          -  Participants that have used use of inhaled, oral, rectal, topical, intramuscular,
             and/or intravenous potent chronic or intermittent corticosteroids (up to 1% topical
             hydrocortisone is permitted).

          -  Participants who work at the study site and/or for the Investigator or are family
             members of study staff and/or the Investigator.