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)
This study has been terminated.
(Study could not be re-supplied with study medication in a timely manner.)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 10, 2008
Last updated: May 1, 2014
Last verified: May 2014
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||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)
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) [ Time Frame: After the first 7 days of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: End of Trial ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2005 (Final data collection date for primary outcome measure)
Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days
Active Comparator: 2
Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
Placebo Comparator: 3
placebo once daily for 28 days
|Ages Eligible for Study:
||12 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 10, 2008
||May 1, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Skin Diseases, Vascular
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs