Comparison of the Effects of Desloratadine and Placebo in the Relief of Nasal Symptom Scores in Subjects With Seasonal Allergic Rhinitis to Cypress Pollen (Study P02836)

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: NCT00867191
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study was to demonstrate the efficacy (% of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Placebo Drug: Desloratadine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Double-Blind, Randomised Comparison Of The Effects Of Desloratadine (Aerius®) And Placebo In The Relief Of Nasal Symptom Scores In Subjects With Seasonal Allergic Rhinitis (Sar) To Cypress Pollen
Actual Study Start Date : February 1, 2002
Actual Primary Completion Date : April 1, 2003
Actual Study Completion Date : April 1, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo, 1 tablet daily, per os
Drug: Placebo
Placebo, 1 tablet daily, per os., 15 days
Active Comparator: 2
Desloratadine, one 5 mg tablet daily, per os
Drug: Desloratadine
Desloratadine, one 5 mg tablet daily, per os, 15 days
Other Name: SCH 34117

Primary Outcome Measures :
  1. The primary objective was to demonstrate the efficacy (as percentage of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen. [ Time Frame: After 14 days of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Patients must be >=18 years of age, of either gender.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g. hormonal contraceptive, medically prescribed intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g. hysterectomy or tubal ligation). Women of childbearing potential who are not currently sexually active must agree and consent to use one of the above-mentioned methods, should they become sexually active while participating in the study.
  • Patients must be in good general health; i.e., they must be free of any clinically significant disease (other than SAR to cypress pollen) that could interfere with study evaluations.
  • Patients must understand and be able to adhere to the measurement, dosing and visit schedules, and agree to report concomitant medications and adverse events to the investigator or designee.
  • Patients must have at least a two-year history (self-reported being acceptable) of intermittent allergic rhinitis specifically from January to March
  • Patients must be clinically symptomatic with SAR to cypress pollen at Visit 2 (Day 0): the total (nasal + non-nasal) symptom score must be >=8 with a nasal congestion score >=2. Patients may be rescheduled up to two additional times for the qualifying visit if they do not meet the minimum symptom scores
  • A positive skin prick test and / or positive cypress-specific IgE by RAST (>= class 2). These tests should have been performed within 24 months before Visit 1
  • Women of childbearing potential must have a negative urine pregnancy test at Visit 2 (Day 0).

Exclusion Criteria:

  • Women who are pregnant or nursing.
  • Patients who have not observed the designated washout periods for any of the prohibited medications.
  • Patients with rhinitis medicamentosa.
  • Patients who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (screening / consent) or patients who have had a viral upper respiratory infection within 7 days prior to Visit 2.
  • Patients who have nasal structural abnormalities, including nasal polyps and marked septal deviation, interfering significantly with nasal airflow.
  • Patients with a history of hypersensitivity to desloratadine or any of its excipients.
  • Patients who are staff personnel directly involved with the administration of this study.
  • Patients previously randomised in this study.
  • Patients having used any investigational drug in the last 30 days prior to Visit 1.
  • Patients who have any current evidence of clinically significant haematopoietic, metabolic, cardiovascular, immunological, neurological, haematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect patient safety.

Study Data/Documents: CSR Synopsis  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00867191     History of Changes
Other Study ID Numbers: P02836
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Dermatologic Agents
Anti-Allergic Agents