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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00783133 |
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 |
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Seasonal Allergic Rhinitis |
Drug: Desloratadine 5 mg Drug: fexofenadine |
Phase IV |
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 |
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 |
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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.
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Drug: Desloratadine 5 mg
Clarinex 5 mg daily x 7 days
Drug: fexofenadine
Allegra 180 mg daily x 7 days
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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.
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Drug: Desloratadine 5 mg
Clarinex 5 mg daily x 7 days
Drug: fexofenadine
Allegra 180 mg daily x 7 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |