A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adults
The purpose of this study is to evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in Adult Men or Women Allergic to Mountain Cedar Pollen|
- To determine the effect of twice daily dosing of intranasal JNJ-17166864, compared to placebo, on nasal symptoms of seasonal allergic rhinitis (nasal congestion, nasal itching, rhinorrhea, and sneezing) [ Time Frame: allergic rhinitis symptom score during treatment phase (2 weeks) ] [ Designated as safety issue: No ]
- To assess safety, tolerability, and pharmacokinetics [ Time Frame: pharmacokinetics and biomarker assessment during treatment phase (2 weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.
|Placebo Comparator: Placebo||
Placebo nasal spray twice daily for 2 weeks.
The study is conducted to prove the hypothesis that JNJ-17466864, as compared to placebo, can provide a 16% or greater improvement in nasal symptoms of seasonal allergic rhinitis. This is a randomized, blinded, placebo-controlled, parallel-group, 2-center outpatient study in adult men or women who have seasonal allergic rhinitis and have 2 year history (or longer) of mild to moderate allergic reaction to mountain cedar pollen. The study will be conducted in mountain cedar pollen season. 72 qualified patients will be admitted to the single-blind 7-day Run-in Period (placebo twice daily) to establish the Baseline allergic rhinitis symptom scores. Patient eligibility to enter the double-blind treatment phase will be based on patients' baseline nasal symptom scores. At least 66 eligible patients whose daytime average nasal symptom scores (of nasal congestion, nasal itching, rhinorrhea, and sneezing) is 2 or greater, with the daytime nasal congestion symptom score 2 or greater, on at least 4 of the 7 Run-in days will be admitted to the double-blind treatment phase, and randomized to either the JNJ-17166864 or placebo treatment group. During the Treatment Phase, patients will self-administer study medication (0.5 mg JNJ-17166864 or placebo per nostril) twice daily for 2 weeks, record allergic rhinitis nasal and ocular symptom scores, and complete the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), to establish the In-Treatment scores. Pharmacokinetic and biomarker samples will be collected during treatment phase. Throughout the study, safety and tolerability will be assessed.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|