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Sponsored by: |
Meda Pharmaceuticals |
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Information provided by: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00660829 |
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: Placebo Drug: 0.15% Azelastine Hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis |
Enrollment: | 536 |
Study Start Date: | December 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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2: Active Comparator
0.15% Azelastine Hydrochloride
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Drug: 0.15% Azelastine Hydrochloride
0.15% Azelastine Hydrochloride 822 mcg
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Allergy and Asthma Center | |
Waco, Texas, United States, 76712 | |
Central Texas Research | |
New Braunfels, Texas, United States, 78130 | |
Sylvana Research Associates | |
San Antonio, Texas, United States, 78229 | |
Biogenics Research Institute | |
San Antonio, Texas, United States, 78229 | |
Allergy and Asthma Center of Austin | |
Austin, Texas, United States, 78759 | |
Allergy and Asthma Associates | |
Austin, Texas, United States, 78731 |
Study Director: | Lewis M Fredane, MD | Meda Pharmaceuticals |
Responsible Party: | Medical and Scientific Affairs ( Harry Sacks, MD Vice President ) |
Study ID Numbers: | MP440 |
Study First Received: | April 14, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00660829 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Otorhinolaryngologic Diseases Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Azelastine Lipoxygenase Inhibitors Histamine Hypersensitivity Respiratory Tract Diseases |
Respiratory Tract Infections Histamine Antagonists Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Histamine phosphate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Rhinitis Azelastine Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Otorhinolaryngologic Diseases Immune System Diseases Anti-Asthmatic Agents Histamine Agents |
Enzyme Inhibitors Anti-Allergic Agents Nose Diseases Pharmacologic Actions Lipoxygenase Inhibitors Histamine Antagonists Autonomic Agents Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Peripheral Nervous System Agents Histamine H1 Antagonists, Non-Sedating Bronchodilator Agents Respiratory Hypersensitivity |