Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00406783
First received: November 29, 2006
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Drug: 5-mg Desloratadine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Intermittent Allergic Rhinitis (IAR)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).


Secondary Outcome Measures:
  • Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.


Other Outcome Measures:
  • Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).

  • Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.


Enrollment: 547
Study Start Date: August 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-mg Desloratadine tablet Drug: 5-mg Desloratadine
5-mg Desloratadine tablet, once daily for 15 days
Other Name: SCH 34117, Aerius
Placebo Comparator: Placebo tablet Drug: Placebo
Placebo tablet, once daily for 15 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The subject must meet ALL of the criteria listed below for entry:

  • For this study, the diagnosis of IAR is not based solely on the current episode of AR. Subjects must have at least a 2 year history of AR consistent with IAR (defined as symptoms of allergic rhinitis present less than four days per week or for less than four consecutive weeks per year); the current episode can count as the second year.
  • Subjects must be 12 years of age and older, of either sex and of any race.
  • At the Run-In Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour AM-PRIOR (reflective) symptoms severity score of at least 6.
  • In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be >= 30.
  • Subjects must have a positive skin-prick test at screening to one or more allergens in the GA2LEN (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active.
  • Subjects must be free of any clinically significant disease, other than IAR, which would interfere with the study evaluations.
  • Subjects, or parents/legal guardians, must give written informed consent. Subjects must be able to adhere to dose and visit schedules and meet study requirements.
  • In females of childbearing potential, the urine pregnancy test (hCG) must be negative at the Screening Visit.
  • Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed intrauterine device (IUD), or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy and tubal ligation), or be at least 1 year postmenopausal.

Exclusion Criteria:

The subject will be excluded from entry if ANY of the criteria listed below are met:

  • Subjects with a history of anaphylaxis and/or severe local reaction(s) to skin testing with allergens.
  • Subjects with intolerable symptoms that would make participating in the study unbearable.
  • Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, and have not had at least a 14-day washout prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening.
  • Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
  • Subjects with current or a history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
  • Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance schedule prior to Visit 1 and staying on this schedule for the remainder of the study.
  • Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids.
  • Subjects who have used any drug or device in an investigational protocol in the 30 days prior to Visit 1.
  • Female subjects who are pregnant or nursing.
  • Subjects with a history of hypersensitivity to the study drug or to their excipients or known to not tolerate any antihistamines.
  • Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staff's family.
  • Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other diseases that preclude the subject's participation in the study.
  • Subjects whose ability to provide informed consent is compromised.
  • Subjects with a history of noncompliance with medications or treatment protocols.
  • Subjects with rhinitis medicamentosa.
  • Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow.
  • Subjects who have not observed the medication washout times outlined in the protocol prior to Visit 2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00406783     History of Changes
Other Study ID Numbers: P04683
Study First Received: November 29, 2006
Results First Received: November 21, 2008
Last Updated: June 5, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Merck Sharp & Dohme Corp.:
Allergic Rhinitis
Intermittent Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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 September 22, 2014