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| Sponsor: | Meda Pharmaceuticals |
|---|---|
| Information provided by: | Meda Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00824473 |
Purpose
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 |
|---|---|---|
|
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: | 506 |
| Study Start Date: | December 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
|
2: Active Comparator
0.15% azelastine hydrochloride
|
Drug: 0.15% azelastine hydrochloride
0.15% azelastine hydrochloride 822 mcg
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Allergy and Asthma Associates | |
| Austin, Texas, United States, 78731 | |
| Allergy and Asthma Center of Austin | |
| Austin, Texas, United States, 78759 | |
| Allergy and Asthma Center | |
| Waco, Texas, United States, 76712 | |
| Sylvana Research Associates | |
| San Antonio, Texas, United States, 78229 | |
| Central Texas Health Research | |
| New Braunfels, Texas, United States, 78130 | |
| Southwest Allergy and Asthma Center, P.A. | |
| San Antonio, Texas, United States, 78229 | |
| Allergy, Asthma Research Center | |
| San Antonio, Texas, United States, 78258 | |
| Study Director: | Lewis M Fredane, MD | Meda Pharmaceuticals |
More Information
| Responsible Party: | Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs ) |
| Study ID Numbers: | MP443 |
| Study First Received: | January 14, 2009 |
| Results First Received: | September 30, 2009 |
| Last Updated: | January 28, 2010 |
| ClinicalTrials.gov Identifier: | NCT00824473 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |