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Sponsored by: |
Alcon Research |
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Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00794144 |
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Drug: Olopatadine Hydrochloride Nasal Spray 0.6% Drug: Olopatadine Hydrochloride Nasal Spray Vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Estimated Enrollment: | 130 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Olopatadine Hydrochloride Nasal Spray 0.6%
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Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
one spray in each nostril twice daily for 2 weeks
|
2: Placebo Comparator
Olopatadine Hydrochloride Nasal Spray Vehicle
|
Drug: Olopatadine Hydrochloride Nasal Spray Vehicle
one spray in each nostril twice daily for 2 weeks
|
Ages Eligible for Study: | 2 Years to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Normal Cardiovascular Ranges
In addition, the Alcon Medical Monitor and/or Principal Investigator may declare any patient ineligible for the study based upon sound medical reasons.
Contact: Cynthia M Rusk | 817-551-8111 ext 8111 | cynthia.rusk@alconlabs.com |
Contact: Enrollment Call Center | 800-4311950 |
United States, Texas | |
Niran Amar, M.D. | Recruiting |
Waco, Texas, United States, 76712 |
Principal Investigator: | Niran Amar, MD | Unaffiliated |
Principal Investigator: | Sheri Byrd, MD | Spartanburg Medical Center |
Principal Investigator: | Albert Finn, MD | National Allergy, Asthma, & Urticaria |
Principal Investigator: | Joseph Flanagan, MD | Health Sciences Research Center |
Principal Investigator: | Brad H Goodman, MD | Aeroallergy Research Laboratories |
Principal Investigator: | Frank Hampel, MD | Central Texas Allergy and Asthma |
Principal Investigator: | Yu-Luen Hsu, MD | West Coast Clinical Trials Phase 2-4 |
Principal Investigator: | Neil Kao, MD | Allergic Disease and Asthma Cente |
Principal Investigator: | John Prestigiacomo, MD | Gulf Coast Research Associates, Inc |
Principal Investigator: | Paul Ratner, MD | Sylvana Research Associates |
Principal Investigator: | Christopher Smith, MD | Asthma and Allergy Associates, P.C. |
Responsible Party: | Alcon Research ( Cynthia M. Rusk\Manager, Development ) |
Study ID Numbers: | C-07-02 |
Study First Received: | November 17, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00794144 |
Health Authority: | United States: Food and Drug Administration |
Allergic Rhinitis Pediatric PATANASE |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Histamine phosphate |
Rhinitis Olopatadine Histamine |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Anti-Allergic Agents Nose Diseases Pharmacologic Actions Histamine Antagonists Sensory System Agents |
Analgesics, Non-Narcotic Therapeutic Uses Histamine H1 Antagonists Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Histamine H1 Antagonists, Non-Sedating Central Nervous System Agents |