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CompletedNCT00783133Updated Aug 15, 2024

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)

A Phase 4 interventional study of Desloratadine 5 mg and fexofenadine in Seasonal Allergic Rhinitis, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Organon and Co · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 5 years 11 months after the study started (first participant enrolled Nov 2002, registered Oct 2008).
Phase
Phase 4
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra 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 Allegra, the patient prefers more.

02

Conditions studied

03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 131 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • had at least a two-year history of seasonal allergic rhinitis;
  • currently experiencing symptoms of SAR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
  • had not taken Allegra® 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 SAR) that would interfere with study evaluations;

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • Experimental
    Clarinex followed by Allegra

    Clarinex 5 mg by mouth daily for 7 days followed by Allegra 180 mg by mouth daily for 7 days, with 5-28 days washout between treatments.

    Drug: Desloratadine 5 mg · Drug: fexofenadine

  • Experimental
    Allegra followed by Clarinex

    Allegra 180 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.

    Drug: Desloratadine 5 mg · Drug: fexofenadine

Interventions

  • DrugDesloratadine 5 mg

    Clarinex 5 mg daily x 7 days

    Also known as: Clarinex, SCH 034117

  • Drugfexofenadine

    Allegra 180 mg daily x 7 days

    Also known as: Allegra®

06

What researchers measure

Primary outcomes

  1. The primary efficacy measure was the preference rates calculated from subject comparative evaluation.

    Time frame: 1 day after the end of each 7-day treatment period (Visit 3 and Visit 5)

Secondary outcomes

  1. 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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00783133
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 31, 2008
Start date
Nov 1, 2002
Primary completion
Jun 1, 2003
Completion
Jun 1, 2003
Last update
Aug 15, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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