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Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)(COMPLETED)
This study has been completed.
First Received: October 30, 2008   No Changes Posted
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00783133
  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 IV

MedlinePlus related topics: Allergy Hay Fever
Drug Information available for: Fexofenadine Fexofenadine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: Preference Evaluation of Clarinex Tablets vs. Allegra Tablets in Subjects With Symptomatic Seasonal Allergic Rhinitis

Further study details as provided by Schering-Plough:

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
Clarinex followed by Allegra: Experimental
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
Drug: fexofenadine
Allegra 180 mg daily x 7 days
Allegra followed by Clarinex: Experimental
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
Drug: fexofenadine
Allegra 180 mg daily x 7 days

  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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P03177
Study First Received: October 30, 2008
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00783133     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Cholinergic Antagonists
Rhinitis
Anti-Allergic Agents
Cholinergic Agents
Desloratadine
Histamine
Hypersensitivity
Histamine Antagonists
Respiratory Tract Diseases
Respiratory Tract Infections
Rhinitis, Allergic, Seasonal
Fexofenadine
Hypersensitivity, Immediate
Histamine phosphate
Histamine H1 Antagonists
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on May 07, 2009