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
About this trial
This is an interventional treatment trial for Urticaria
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.
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
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)
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