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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783133
First received: October 30, 2008
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Desloratadine 5 mg
Drug: fexofenadine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Preference Evaluation of Clarinex Tablets vs. Allegra Tablets in Subjects With Symptomatic Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: November 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Clarinex 5 mg daily x 7 days
Other Name: Clarinex, SCH 034117
Drug: fexofenadine
Allegra 180 mg daily x 7 days
Other Name: Allegra®
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
Clarinex 5 mg daily x 7 days
Other Name: Clarinex, SCH 034117
Drug: fexofenadine
Allegra 180 mg daily x 7 days
Other Name: Allegra®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00783133     History of Changes
Other Study ID Numbers: P03177
Study First Received: October 30, 2008
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Desloratadine
Fexofenadine
Loratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on September 11, 2014