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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00276016 |
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.
Condition | Intervention | Phase |
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Rhinitis, Allergic, Seasonal |
Drug: phenylephrine, pseudoephedrine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following minimum scores at some point during each of the 120-minute screening period challenge sessions:
Exclusion Criteria :
Study ID Numbers: | P04579 |
Study First Received: | January 11, 2006 |
Last Updated: | November 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00276016 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Pseudoephedrine Otorhinolaryngologic Diseases SARS Rhinitis Naphazoline Oxymetazoline Hypersensitivity Respiratory Tract Diseases |
Respiratory Tract Infections Guaifenesin Phenylephrine Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Ephedrine Phenylpropanolamine Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Physiological Effects of Drugs Adrenergic Agonists Nasal Decongestants Therapeutic Uses Vasoconstrictor Agents Appetite Depressants Adrenergic alpha-Agonists Immune System Diseases Sympathomimetics |
Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents Protective Agents Pharmacologic Actions Nose Diseases Anti-Obesity Agents Mydriatics Autonomic Agents Expectorants Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |