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)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00867191
First received: March 20, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: Desloratadine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: February 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00867191     History of Changes
Other Study ID Numbers: P02836
Study First Received: March 20, 2009
Last Updated: March 20, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 17, 2014