Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age

NCT ID: NCT00794144

Last Updated: 2010-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31

Brief Summary

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

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Olopatadine Hydrochloride Nasal Spray 0.6%

Group Type: EXPERIMENTAL

Olopatadine Hydrochloride Nasal Spray 0.6%

Intervention Type: DRUG

one spray in each nostril twice daily for 2 weeks

2

Olopatadine Hydrochloride Nasal Spray Vehicle

Group Type: PLACEBO_COMPARATOR

Olopatadine Hydrochloride Nasal Spray Vehicle

Intervention Type: DRUG

one spray in each nostril twice daily for 2 weeks

Interventions

Olopatadine Hydrochloride Nasal Spray 0.6%

one spray in each nostril twice daily for 2 weeks

Intervention Type: DRUG

Olopatadine Hydrochloride Nasal Spray Vehicle

one spray in each nostril twice daily for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient must be at least 2 years of age and less than 6 years of age on Day 1;
• Parent/legal guardian must be willing and able to give written informed consent and must provide this consent for the study;
• Patient must have a positive case history of allergic rhinitis symptoms and at least one documented positive skin test within the 5 years prior to Day 1 of the following type: skin prick test, intradermal test or RAST test(radioallergosorbent test) for an allergen (≥ 3 mm wheal greater than diluent after skin prick testing; ≥ 7 mm wheal greater than the diluent after intradermal testing; or positive level 2 or greater after RAST testing);
• Patient and parent/caregiver must be willing and able to make required study visits;
• Patient and parent/caregiver must be able to follow instructions;
• Nasal exam must confirm absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations at Screening and prior to administration of test article at the Day 1 Visit. A finding of 'present' for any of these parameters disqualifies the patient from the study, regardless of clinical relevance.

Exclusion Criteria

• The need for chronic or intermittent use of any prescription or over-the-counter nasal spray during the study period;
• Use of any form of olopatadine (e.g., PATANOL®, PATADAY™, PATANASE®) within 7 days of Day 1;
• Current or recent (within the last 14 days) use of any drugs/drug classes or combinations thereof that may prolong the QT interval;
• Patients with a history or evidence of nasolacrimal drainage system malfunction or abnormality that may interfere with the results of the study;
• Concurrent disease that might complicate or interfere with the investigation or evaluation of the study medications (such as rhinitis medicamentosa or large obstructive nasal polyps);
• Patients with syndromes associated with midfacial deformities or other anatomic nasal deformity that may interfere with the patient's participation in the study, as identified by physical or nasal examination at Screening or Day 1;
• Diagnosis of acute sinusitis within 30 days of Day 1 or diagnosis of chronic rhinosinusitis within one year of Day 1;
• Congestion that would, in the opinion of the investigator, interfere with successful nasal drug administration/absorption (in either nostril);
• Upper or lower respiratory infection within 14 days of Day 1;
• Asthma, with the exception of intermittent asthma as outlined in Section 18.5, from the Stepwise Approach for Managing Asthma in Children 0-4 Years of Age, and Stepwise Approach for Managing Asthma in Children 5-11 Years of Age (5);
• Current or recent (< 6 months) history of severe, unstable, or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal disease, or evidence of other diseases at the physical examination conducted at the Screening Visit, which in the opinion of the Investigator would preclude the safe participation of the patient in the study;
• Hypersensitivity to olopatadine, benzalkonium chloride, or any component of the test articles;
• History or current infection of HIV (Human Immunodeficiency Virus), hepatitis B or C or A, as indicated by the patient's parent or legal guardian response on the HIV/Hepatitis survey;
• Relatives of study site staff or other individuals who would have access to the clinical study protocol;
• A family member or any individual residing in the same household of a patient that is currently enrolled in the study;
• Participation in any other investigational study within 30 days before entry into this study (Day 1), or concomitantly with this study;
• Clinically relevant abnormal vital signs (pulse rate, average systolic and diastolic blood pressure) at Screening or Day 1. The ranges below have been designated as normal for the study. Inclusion of patients with values outside of these normal ranges is at the discretion of the study investigator;

Normal Cardiovascular Ranges

• Systolic Blood Pressure - 86 to 116 mmHg (millimeters mercury)
• Diastolic Blood Pressure -50 to 78 mmHg
• Pulse - 75 to 130 bpm (beats per minute)

In addition, the Alcon Medical Monitor and/or Principal Investigator may declare any patient ineligible for the study based upon sound medical reasons.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Alcon Research

Principal Investigators

Niran Amar, MD

Role: PRINCIPAL_INVESTIGATOR

Sheri Byrd, MD

Role: PRINCIPAL_INVESTIGATOR

Spartanburg Medical Center

Albert Finn, MD

Role: PRINCIPAL_INVESTIGATOR

National Allergy, Asthma, & Urticaria

Joseph Flanagan, MD

Role: PRINCIPAL_INVESTIGATOR

Health Sciences Research Center

Brad H Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

Aeroallergy Research Laboratories

Frank Hampel, MD

Role: PRINCIPAL_INVESTIGATOR

Central Texas Allergy and Asthma

Yu-Luen Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

West Coast Clinical Trials Phase 2-4

Neil Kao, MD

Role: PRINCIPAL_INVESTIGATOR

Allergic Disease and Asthma Cente

John Prestigiacomo, MD

Role: PRINCIPAL_INVESTIGATOR

Gulf Coast Research Associates, Inc

Paul Ratner, MD

Role: PRINCIPAL_INVESTIGATOR

Sylvana Research Associates

Christopher Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Asthma and Allergy Associates, P.C.

Locations

Niran Amar, M.D.

Waco, Texas, United States

Countries

United States

Other Identifiers

C-07-02

Identifier Type: -

Identifier Source: org_study_id