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Sponsored by: |
Meda Pharmaceuticals |
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Information provided by: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00720278 |
The purpose of this study was to determine if two allergy medications are more effective than placebo.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis |
Drug: 0.15% azelastine hydrochloride 1644 mcg daily Drug: 0.1% azelastine hydrochloride 1096 mcg daily Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 Compared to Placebo in Patients With Seasonal Allergic Rhinitis |
Estimated Enrollment: | 540 |
Study Start Date: | August 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo
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Drug: Placebo |
2: Experimental
0.1% azelastine hydrochloride
|
Drug: 0.1% azelastine hydrochloride 1096 mcg daily |
3: Experimental
0.15% azelastine hydrochloride
|
Drug: 0.15% azelastine hydrochloride 1644 mcg daily |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Med Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs ) |
Study ID Numbers: | MP438 |
Study First Received: | July 21, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00720278 |
Health Authority: | United States: Food and Drug Administration |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate |
Histamine phosphate Rhinitis Azelastine Histamine Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Histamine Agents Enzyme Inhibitors Anti-Allergic Agents Nose Diseases |
Pharmacologic Actions Lipoxygenase Inhibitors Histamine Antagonists Autonomic Agents Therapeutic Uses Histamine H1 Antagonists Peripheral Nervous System Agents Histamine H1 Antagonists, Non-Sedating Bronchodilator Agents |