- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751166
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)
February 7, 2022 updated by: Organon and Co
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)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
149
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
placebo
|
placebo once daily for 28 days
|
Experimental: 1
Desloratadine
|
Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days
|
Active Comparator: 2
Cetirizine
|
Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After the first 7 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
At treatment days 14 and 28 (Visit 3 and 4)
|
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
|
Days 7, 14, 21 and 28
|
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
|
Days 7, 14, 21 and 28
|
Adverse Events
Time Frame: End of Trial
|
End of Trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2004
Primary Completion (Actual)
May 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
September 10, 2008
First Submitted That Met QC Criteria
September 10, 2008
First Posted (Estimate)
September 11, 2008
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Chronic Urticaria
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
- Desloratadine
Other Study ID Numbers
- P03736
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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