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Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

Primary Purpose

Vasomotor Rhinitis, Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg
Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Phenylephrine Hydrochloride Extended Release Tablets, 30 mg

    Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion
    Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference

    Secondary Outcome Measures

    Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets
    Convenience was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Secondary Endpoint Which product, if any, was more convenient? The possible answers were: I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference

    Full Information

    First Posted
    September 11, 2009
    Last Updated
    February 20, 2015
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00976209
    Brief Title
    Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
    Official Title
    A Randomized, Two-Way Crossover, Multicenter, Consumer Preference Study of Two Oral Formulations of Phenylephrine Hydrochloride.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vasomotor Rhinitis, Seasonal Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    331 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phenylephrine Hydrochloride Extended Release Tablets, 30 mg
    Arm Type
    Experimental
    Arm Title
    Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg
    Intervention Description
    Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
    Other Intervention Name(s)
    Sudafed PE®
    Intervention Description
    Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion
    Description
    Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference
    Time Frame
    Visit 6 (Period 2, Day 4)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets
    Description
    Convenience was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Secondary Endpoint Which product, if any, was more convenient? The possible answers were: I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference
    Time Frame
    Visit 6 (Period 2, Day 4)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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    Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

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