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

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:
  • Clarinex, SCH 34117
Zyrtec 10 mg daily x 7 days
Other Names:
  • Zyrtec®
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:
  • Clarinex, SCH 34117
Zyrtec 10 mg daily x 7 days
Other Names:
  • Zyrtec®

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

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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