- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406783
Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)
February 7, 2022 updated by: Organon and Co
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)
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
547
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 5-mg Desloratadine tablet
|
5-mg Desloratadine tablet, once daily for 15 days
Other Names:
|
PLACEBO_COMPARATOR: Placebo tablet
|
Placebo tablet, once daily for 15 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit
Time Frame: 15 days
|
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.
|
15 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE
Time Frame: Baseline
|
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).
|
Baseline
|
Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (ACTUAL)
November 1, 2007
Study Completion (ACTUAL)
November 1, 2007
Study Registration Dates
First Submitted
November 29, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (ESTIMATE)
December 4, 2006
Study Record Updates
Last Update Posted (ACTUAL)
February 15, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Desloratadine
Other Study ID Numbers
- P04683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rhinitis, Allergic, Perennial
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
United Allergy ServicesCompletedPerennial Allergic Rhinitis With Seasonal VariationUnited States
-
Eli Lilly and CompanyNot yet recruitingPerennial Allergic Rhinitis (PAR)United States
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
Teva Branded Pharmaceutical Products R&D, Inc.United BioSource, LLCCompletedEffectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis (BALANCE)Perennial Allergic Rhinitis (PAR)United States
-
SanofiCompleted
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
Clinical Trials on 5-mg Desloratadine
-
Organon and CoCompletedChronic Idiopathic Urticaria
-
Organon and CoCompletedDermatitis | Eczema | Dermal Pruritus
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompletedSeasonal Allergic Rhinitis
-
Organon and CoCompletedSeasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedSeasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis