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Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
desloratadine
fexofenadine
placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

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

Inclusion Criteria:

  • have demonstrated their willingness to participate in the study and comply with its procedures, including adherence to dosing and visit schedules by signing a written informed consent (the parent/guardian of a subject under 18 years of age also had to sign the informed consent form);
  • have been 12 years of age or older, of either sex and any race;
  • have had at least a 2-year history (self-reported history was acceptable) of seasonal allergic rhinitis occurring during the same season(s) as the current study;
  • have been skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with a wheal diameter at least 7 mm larger than the diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, which could include seasonal molds, prevalent in the geographical area of the study site during the study period;
  • if female and of childbearing potential (including women who were less than 1 year postmenopausal and women who became sexually active during the study), have been using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation);
  • if female and of childbearing potential, have had a negative urine pregnancy test at Baseline;
  • have been free of any clinically significant disease (other than SAR) that would interfere with study evaluations;
  • have understood and been able to adhere to the dosing and visit schedules, and agreed to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary;
  • have met the following at the Screening Visit: total symptom score (TSS) of 6 or greater (not including congestion), with 2 or more symptoms rated as moderate (2) or severe (3) and no symptom rated as very severe (4) during the 12 hours prior to this visit;
  • have met the following on the morning of the Baseline Visit: symptom severity score 7 AM instantaneous TSS of 6 or more (not including congestion), with 2 or more symptoms rated as moderate (2) or severe (3), and no symptom rated as very severe (4).

Exclusion Criteria:

  • if female, were pregnant, intended to become pregnant during the study, or were nursing;
  • had not observed the designated washout periods for any of the prohibited medications;
  • had current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precluded the subject's participation in the study; particular attention was to be given to conditions that would interfere with the absorption, distribution, metabolism or excretion of the study drug, or with the subject's ability to complete the diary cards;
  • had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, may have interfered with the study evaluation or affected subject safety;
  • were in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study;
  • were participating in any other clinical study(ies);
  • were part of the investigational study staff or a family member of the staff personnel directly involved with this study;
  • had asthma, with the exception of mild intermittent asthma, ie, controlled with the use of short acting, beta2-agonist adrenoreceptor rescue medication;
  • had a current or past history of frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip;
  • had rhinitis medicamentosa;
  • had a history of intranasal drug abuse;
  • had a history of hypersensitivity to the study drugs or their excipients, or to Claritin;
  • had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening, or had persistent symptoms at the time of the Screening Visit;
  • had nasal structural abnormalities, including nasal polyps easily visible on physical examination and marked septum deviation that significantly interfered with nasal airflow;
  • in the opinion of the investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids;
  • if on immunotherapy (desensitization therapy) should not have had a change in dose during the study, and should have remained on the same dose throughout the trial; were not to have received desensitization treatment within 24 hours prior to a visit;
  • had been previously randomized into the study at any study site;
  • ability to provide informed consent was compromised;
  • had a history of non-compliance with medications or treatment protocols;
  • had a history of difficulty swallowing pills or had known upper gastrointestinal narrowing or abnormal esophageal peristalsis;
  • was a night-shift worker or did not have a standard asleep at night / awake during the day cycle;
  • planned to travel outside of the study area during the time of their participation in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    desloratadine

    fexofenadine

    placebo

    Outcomes

    Primary Outcome Measures

    Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment

    Secondary Outcome Measures

    Change from Baseline in the mean AM/PM self-rated 12-hour reflective TSS (not including nasal congestion) averaged over the 15 days of treatment.
    Change from Baseline in the mean AM self-rated instantaneous individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
    Change from Baseline in the mean AM/PM self-rated 12-hour reflective individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
    Joint physician-patient evaluation of response to therapy.

    Full Information

    First Posted
    October 30, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00783211
    Brief Title
    Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)
    Official Title
    A Placebo Controlled Study of the Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. in the Treatment of Subjects With Symptomatic Seasonal Allergic Rhinitis (SAR)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2004 (Actual)
    Primary Completion Date
    October 1, 2004 (Actual)
    Study Completion Date
    October 1, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    722 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    desloratadine
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    fexofenadine
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    desloratadine
    Other Intervention Name(s)
    SCH 34117; Clarinex
    Intervention Description
    desloratadine, 5 mg oral tablets, once daily for 15 days
    Intervention Type
    Drug
    Intervention Name(s)
    fexofenadine
    Other Intervention Name(s)
    Allegra
    Intervention Description
    fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo, once daily for 15 days
    Primary Outcome Measure Information:
    Title
    Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment
    Time Frame
    15 days
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in the mean AM/PM self-rated 12-hour reflective TSS (not including nasal congestion) averaged over the 15 days of treatment.
    Time Frame
    15 days
    Title
    Change from Baseline in the mean AM self-rated instantaneous individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
    Time Frame
    15 days
    Title
    Change from Baseline in the mean AM/PM self-rated 12-hour reflective individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
    Time Frame
    15 days
    Title
    Joint physician-patient evaluation of response to therapy.
    Time Frame
    Day 8 and Day 15

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have demonstrated their willingness to participate in the study and comply with its procedures, including adherence to dosing and visit schedules by signing a written informed consent (the parent/guardian of a subject under 18 years of age also had to sign the informed consent form); have been 12 years of age or older, of either sex and any race; have had at least a 2-year history (self-reported history was acceptable) of seasonal allergic rhinitis occurring during the same season(s) as the current study; have been skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with a wheal diameter at least 7 mm larger than the diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, which could include seasonal molds, prevalent in the geographical area of the study site during the study period; if female and of childbearing potential (including women who were less than 1 year postmenopausal and women who became sexually active during the study), have been using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation); if female and of childbearing potential, have had a negative urine pregnancy test at Baseline; have been free of any clinically significant disease (other than SAR) that would interfere with study evaluations; have understood and been able to adhere to the dosing and visit schedules, and agreed to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary; have met the following at the Screening Visit: total symptom score (TSS) of 6 or greater (not including congestion), with 2 or more symptoms rated as moderate (2) or severe (3) and no symptom rated as very severe (4) during the 12 hours prior to this visit; have met the following on the morning of the Baseline Visit: symptom severity score 7 AM instantaneous TSS of 6 or more (not including congestion), with 2 or more symptoms rated as moderate (2) or severe (3), and no symptom rated as very severe (4). Exclusion Criteria: if female, were pregnant, intended to become pregnant during the study, or were nursing; had not observed the designated washout periods for any of the prohibited medications; had current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precluded the subject's participation in the study; particular attention was to be given to conditions that would interfere with the absorption, distribution, metabolism or excretion of the study drug, or with the subject's ability to complete the diary cards; had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, may have interfered with the study evaluation or affected subject safety; were in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study; were participating in any other clinical study(ies); were part of the investigational study staff or a family member of the staff personnel directly involved with this study; had asthma, with the exception of mild intermittent asthma, ie, controlled with the use of short acting, beta2-agonist adrenoreceptor rescue medication; had a current or past history of frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip; had rhinitis medicamentosa; had a history of intranasal drug abuse; had a history of hypersensitivity to the study drugs or their excipients, or to Claritin; had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening, or had persistent symptoms at the time of the Screening Visit; had nasal structural abnormalities, including nasal polyps easily visible on physical examination and marked septum deviation that significantly interfered with nasal airflow; in the opinion of the investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids; if on immunotherapy (desensitization therapy) should not have had a change in dose during the study, and should have remained on the same dose throughout the trial; were not to have received desensitization treatment within 24 hours prior to a visit; had been previously randomized into the study at any study site; ability to provide informed consent was compromised; had a history of non-compliance with medications or treatment protocols; had a history of difficulty swallowing pills or had known upper gastrointestinal narrowing or abnormal esophageal peristalsis; was a night-shift worker or did not have a standard asleep at night / awake during the day cycle; planned to travel outside of the study area during the time of their participation in the study.

    12. IPD Sharing Statement

    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)

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