Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
AA 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)(COMPLETED)
This study has been completed.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00751218
  Purpose

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 Intervention Phase
Urticaria
Drug: desloratadine
Drug: placebo
Drug: cetirizine
Phase IV

MedlinePlus related topics: Hives Itching
Drug Information available for: Cetirizine Cetirizine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Schering-Plough:

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) after the first 7 days of treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse event reports and vital sign evaluations [ Time Frame: Upon occurance ] [ Designated as safety issue: Yes ]

Enrollment: 174
Study Start Date: May 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Active Comparator
desloratadine
Drug: desloratadine
desloratadine, 5mg oral tablets, once daily for 28 days
Arm 2: Placebo Comparator
Placebo
Drug: placebo
placebo, once daily for 28 days
Arm 3: Active Comparator
cetirizine
Drug: cetirizine
cetirizine, 10 mg capsules once daily for 28 days

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P03735
Study First Received: September 10, 2008
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00751218  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Skin Diseases
Hypersensitivity, Immediate
Histamine phosphate
Urticaria
Cetirizine
Desloratadine
Histamine

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

ClinicalTrials.gov processed this record on January 16, 2009