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

NCT00406783 | Completed Phase 3 Results

• 1 other identifier: P04683
• Study Type: interventional
• Target: 547
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial

Keywords

Allergic Rhinitis; Intermittent Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  15 days

Secondary Outcomes (1)

• Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit

  15 days

Other Outcomes (2)

• Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE

  Baseline

• Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE

  Baseline

Study Arms (2)

5-mg Desloratadine tablet

EXPERIMENTAL

Drug: 5-mg Desloratadine

Placebo tablet

PLACEBO COMPARATOR

Drug: Placebo

Interventions

5-mg Desloratadine DRUG

5-mg Desloratadine tablet, once daily for 15 days

Also known as: SCH 34117, Aerius

5-mg Desloratadine tablet

Placebo DRUG

Placebo tablet, once daily for 15 days

Placebo tablet

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Bousquet J, Bachert C, Canonica GW, Mullol J, Van Cauwenberge P, Bindslev Jensen C, Fokkens WJ, Ring J, Keith P, Lorber R, Zuberbier T; ACCEPT-1 study group. Efficacy of desloratadine in intermittent allergic rhinitis: a GA(2)LEN study. Allergy. 2009 Oct;64(10):1516-1523. doi: 10.1111/j.1398-9995.2009.02115.x. Epub 2009 Jul 14.

  PMID: 19624554 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 20, 2024
• Results First Posted: March 6, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share