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Trial record 19 of 10796 for:    Placebo AND once

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 P03735)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751218
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Urticaria Drug: desloratadine Drug: placebo Drug: cetirizine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 6, 2004
Actual Primary Completion Date : May 24, 2005
Actual Study Completion Date : May 24, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Active Comparator: Arm 1
Drug: desloratadine
desloratadine, 5mg oral tablets, once daily for 28 days
Other Name: SCH 034117

Placebo Comparator: Arm 2
Drug: placebo
placebo, once daily for 28 days

Active Comparator: Arm 3
Drug: cetirizine
cetirizine, 10 mg capsules once daily for 28 days

Primary Outcome Measures :
  1. 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) after the first 7 days of treatment. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Joint physician-patient evaluations ("now") at treatment days 14 and 28 (Visit 3 and 4) of overall condition of the CIU and overall global therapeutic response [ Time Frame: Days 14 and 28 (visits 3 and 4) ]
  2. Average AM/PM "reflective" diary scores over for: severity of pruritus; number of hives; size of largest hives; total symptom score; subject-evaluated CIU interference with sleep (AM) and interference with daily activities (PM). [ Time Frame: Treatment days 1-7, 8-14, 15-21 and 22-28 ]
  3. Adverse event reports and vital sign evaluations [ Time Frame: Upon occurance ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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 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

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, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precluded the subject's participation in the study. Particular attention was to be given to subjects with conditions that would interfere with the absorption, 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 Data/Documents: CSR Synopsis  This link exits the site

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00751218     History of Changes
Other Study ID Numbers: P03735
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Dermatologic Agents