search
Back to results

A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)

Primary Purpose

Urticaria

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Desloratadine
Cetirizine
placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria

Eligibility Criteria

12 Years - 70 Years (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 by signing a written informed consent. For pediatric patients, the parent or legal guardian was to have signed a written informed consent.
  • Be between 12 and 70 years of age, of either sex and any race.
  • Have had signs and symptoms of CIU for at least 6 weeks prior to the Screening Visit.
  • Have been experiencing a current flare of their CIU of at least 3 weeks prior to the Baseline Visit. Hives were to have been present for at least 3 days per week during the current flare prior to the Baseline Visit.
  • Have an overall condition of CIU that was at least of "moderate" severity (minimum score of 2) at both Screening and Baseline Visits.
  • Have at least a moderately severe pruritus score (minimum score of 2) and hives (minimum score of 1) present at Screening.
  • Have, at Baseline, a total pruritus score of 14 or greater for the sum of AM and PM (reflective) diary scores for the 3 days prior to Baseline and the AM diary score on Day 1.
  • Understand and be able to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times,concomitant medications, and adverse events accurately and consistently in a daily diary.
  • Be in general good health and free of any clinically significant disease (other than CIU) that would have interfered with study evaluations.
  • If female and of childbearing potential, have had a negative urine (hCG) pregnancy test at the time of Baseline (Visit 2).
  • Female subjects of childbearing potential were to be counseled in the appropriate use of birth control while in the study. They were to be using a medically accepted method of birth control, for example: double barrier method, oral contraceptive, Depo-Provera®, or Norplant®, prior to Baseline and during the study. Women who were not sexually active were to agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. If the subject had had a tubal ligation or was using an intra-uterine device, or if the husband/partner had had a vasectomy, another method was to be used.

Exclusion Criteria:

  • Had asthma requiring chronic use of inhaled or systemic corticosteroids.
  • Had been unresponsive to antihistamine treatment in the past.
  • Had a history of allergies to more than two classes of medication or who were allergic to or unable to tolerate antihistamines.
  • Had used any investigational drug in the last 30 days prior to Baseline.
  • Had food or drug allergies manifested as skin reactions. Subjects with urticaria that was primarily due to physical urticaria or other known etiology.
  • If female, were pregnant or nursing.
  • Had a history of hypersensitivity to the study drug or its excipients.
  • Were family members of the investigational study staff involved with this study.
  • Had previously been randomized into the study.
  • Had current evidence of clinically significant hematopoietic, cardi distribution, metabolism, or excretion of the study medication or with the subject's ability to reliably complete the diary card.
  • Were morbidly obese (BMI >= 35, as described in Appendix 6 of the protocol)
  • Had a compromised ability to provide informed consent.
  • Had a history of non-compliance with medications or treatment protocols.

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

    Cetirizine

    placebo

    Outcomes

    Primary Outcome Measures

    Compare the efficacy of the study treatments with respect to the change from Baseline in the average AM/PM 12-hour reflective pruritus severity score (diary recordings)

    Secondary Outcome Measures

    Joint physician-patient evaluations ("now") of: overall condition of the CIU and overall global therapeutic response.
    Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: severity of pruritus; number of hives; size of largest hives; total symptom score (pruritus, number of hives, size of the largest hives)
    Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: subject-evaluated CIU interference with sleep (AM) and interference with daily activities (PM)
    Adverse Events

    Full Information

    First Posted
    September 10, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00751166
    Brief Title
    A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)
    Official Title
    A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (CIU)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study could not be re-supplied with study medication in a timely manner.
    Study Start Date
    March 1, 2004 (Actual)
    Primary Completion Date
    May 1, 2005 (Actual)
    Study Completion Date
    May 1, 2005 (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 (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-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
    Urticaria

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Desloratadine
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Cetirizine
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Desloratadine
    Intervention Description
    Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Cetirizine
    Intervention Description
    Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo once daily for 28 days
    Primary Outcome Measure Information:
    Title
    Compare the efficacy of the study treatments with respect to the change from Baseline in the average AM/PM 12-hour reflective pruritus severity score (diary recordings)
    Time Frame
    After the first 7 days of treatment
    Secondary Outcome Measure Information:
    Title
    Joint physician-patient evaluations ("now") of: overall condition of the CIU and overall global therapeutic response.
    Time Frame
    At treatment days 14 and 28 (Visit 3 and 4)
    Title
    Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: severity of pruritus; number of hives; size of largest hives; total symptom score (pruritus, number of hives, size of the largest hives)
    Time Frame
    Days 7, 14, 21 and 28
    Title
    Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: subject-evaluated CIU interference with sleep (AM) and interference with daily activities (PM)
    Time Frame
    Days 7, 14, 21 and 28
    Title
    Adverse Events
    Time Frame
    End of Trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent. For pediatric patients, the parent or legal guardian was to have signed a written informed consent. Be between 12 and 70 years of age, of either sex and any race. Have had signs and symptoms of CIU for at least 6 weeks prior to the Screening Visit. Have been experiencing a current flare of their CIU of at least 3 weeks prior to the Baseline Visit. Hives were to have been present for at least 3 days per week during the current flare prior to the Baseline Visit. Have an overall condition of CIU that was at least of "moderate" severity (minimum score of 2) at both Screening and Baseline Visits. Have at least a moderately severe pruritus score (minimum score of 2) and hives (minimum score of 1) present at Screening. Have, at Baseline, a total pruritus score of 14 or greater for the sum of AM and PM (reflective) diary scores for the 3 days prior to Baseline and the AM diary score on Day 1. Understand and be able to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times,concomitant medications, and adverse events accurately and consistently in a daily diary. Be in general good health and free of any clinically significant disease (other than CIU) that would have interfered with study evaluations. If female and of childbearing potential, have had a negative urine (hCG) pregnancy test at the time of Baseline (Visit 2). Female subjects of childbearing potential were to be counseled in the appropriate use of birth control while in the study. They were to be using a medically accepted method of birth control, for example: double barrier method, oral contraceptive, Depo-Provera®, or Norplant®, prior to Baseline and during the study. Women who were not sexually active were to agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. If the subject had had a tubal ligation or was using an intra-uterine device, or if the husband/partner had had a vasectomy, another method was to be used. Exclusion Criteria: Had asthma requiring chronic use of inhaled or systemic corticosteroids. Had been unresponsive to antihistamine treatment in the past. Had a history of allergies to more than two classes of medication or who were allergic to or unable to tolerate antihistamines. Had used any investigational drug in the last 30 days prior to Baseline. Had food or drug allergies manifested as skin reactions. Subjects with urticaria that was primarily due to physical urticaria or other known etiology. If female, were pregnant or nursing. Had a history of hypersensitivity to the study drug or its excipients. Were family members of the investigational study staff involved with this study. Had previously been randomized into the study. Had current evidence of clinically significant hematopoietic, cardi distribution, metabolism, or excretion of the study medication or with the subject's ability to reliably complete the diary card. Were morbidly obese (BMI >= 35, as described in Appendix 6 of the protocol) Had a compromised ability to provide informed consent. Had a history of non-compliance with medications or treatment protocols.

    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

    A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)

    We'll reach out to this number within 24 hrs