Overview

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

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Desloratadine
Loratadine
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.