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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00319995 |
This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.
Condition | Intervention | Phase |
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Rhinitis, Allergic, Seasonal |
Drug: loratadine; montelukast |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis |
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject’s ability to complete or reliably complete the diary card.
Study ID Numbers: | P04095, Doc ID 3058224;, SCH 445761 |
Study First Received: | April 28, 2006 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00319995 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Adrenergic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Rhinitis Hormones Leukotriene Antagonists Nasal Decongestants Hypersensitivity Loratadine Respiratory Tract Infections Respiratory Tract Diseases Phenylephrine Vasoconstrictor Agents Antipruritics |
Pseudoephedrine Otorhinolaryngologic Diseases Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents Anti-Allergic Agents Histamine Montelukast Oxymetazoline Histamine Antagonists Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists Ephedrine |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Rhinitis Leukotriene Antagonists Nasal Decongestants Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Loratadine Therapeutic Uses |
Vasoconstrictor Agents Antipruritics Dermatologic Agents Pseudoephedrine Otorhinolaryngologic Diseases Immune System Diseases Sympathomimetics Histamine Agents Anti-Asthmatic Agents Central Nervous System Stimulants Anti-Allergic Agents Cardiovascular Agents Nose Diseases Pharmacologic Actions Montelukast |