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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00311844 |
This study was a double-blind, placebo-controlled, cross-over, single-center study of desloratadine 5 mg or placebo in subjects 18 years of age or older with a history of seasonal allergic rhinoconjunctivitis. This study was performed to examine the effects of desloratadine compared with placebo, on the signs and symptoms of allergic conjunctivitis induced by direct conjunctival challenges with a previously identified sensitizing antigen, in the eyes of a subject known to be sensitive to the antigen.
Condition | Intervention | Phase |
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Conjunctivitis, Allergic |
Drug: desloratadine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Crossover, Single-Center Study to Evaluate the Anti-Allergic and Anti-Inflammatory Effects of Multiple Doses of Desloratadine on Conjunctival Allergen Challenge-Induced Ocular Signs and Symptoms |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(details in section 8.2.6 and 8.3.2 of the protocol)
Exclusion Criteria:
Study ID Numbers: | P04209 |
Study First Received: | April 4, 2006 |
Last Updated: | May 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00311844 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Conjunctivitis, Allergic Cholinergic Antagonists Eye Diseases Conjunctivitis Anti-Allergic Agents Cholinergic Agents Desloratadine |
Conjunctival Diseases Histamine Signs and Symptoms Hypersensitivity Histamine Antagonists Hypersensitivity, Immediate Histamine phosphate Histamine H1 Antagonists |
Neurotransmitter Agents Conjunctivitis, Allergic Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Eye Diseases Physiological Effects of Drugs Histamine Agents Conjunctivitis Cholinergic Agents |
Desloratadine Pharmacologic Actions Conjunctival Diseases Signs and Symptoms Hypersensitivity Histamine Antagonists Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |