- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794846
Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03180)
February 7, 2022 updated by: Organon and Co
Preference Evaluation of Clarinex Tablets vs. Zyrtec Tablets in Subjects With Symptomatic Allergic Rhinitis
This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®.
Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment.
At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 4
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
- currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
- had not taken Zyrtec® or Clarinex® within the previous year;
- were 18 years of age or older;
- had negative urine test (hCG) for females of childbearing potential;
- for women of childbearing potential, agreed to use a medically accepted method of birth control;
- were free of any clinically significant disease (other than AR) that would interfere with study evaluations.
Exclusion Criteria:
- were pregnant or nursing;
- had allergic or idiosyncratic reaction to antihistamines;
- had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
- had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
- in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
- had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
- had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
- were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
- had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
- had a history of non-compliance with medications or treatment protocols;
- had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
- had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
- had liver or renal impairment.
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clarinex followed by Zyrtec
Clarinex 5 mg by mouth daily for 7 days followed by Zyrtec 10 mg by mouth daily for 7 days, with 5-28 days washout between treatments.
|
Clarinex 5 mg daily x 7 days
Other Names:
Zyrtec 10 mg daily x 7 days
Other Names:
|
Experimental: Zyrtec followed by Clarinex
Zyrtec 10 mg by mouth daily for 7 days followed by Clarinex 5 mg by mouth daily for 7 days, with 5-28 days washout between treatments.
|
Clarinex 5 mg daily x 7 days
Other Names:
Zyrtec 10 mg daily x 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy measure was the preference rates calculated from subject comparative evaluation.
Time Frame: 1 day after the last treatment period (Visit 5)
|
1 day after the last treatment period (Visit 5)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subject Non-Comparative Evaluation and subject Response to Therapy
Time Frame: 1 day after the end of each 7-day treatment period (Visit 3 and Visit 5)
|
1 day after the end of each 7-day treatment period (Visit 3 and Visit 5)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2002
Primary Completion (Actual)
May 1, 2003
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
November 19, 2008
First Submitted That Met QC Criteria
November 19, 2008
First Posted (Estimate)
November 20, 2008
Study Record Updates
Last Update Posted (Actual)
February 17, 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
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
- Desloratadine
Other Study ID Numbers
- P03180
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.
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