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| ID | Type | Description | Link |
|---|---|---|---|
| 17166864NAP2001 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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The purpose of this study is to evaluate the clinical effectiveness, safety and pharmacokinetics of JNJ-17166864 in patients with seasonal allergic rhinitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-17166864 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-17166864 | Drug | JNJ-17166864 0.5 mg per nostril twice daily for 2 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | allergic rhinitis symptom score during treatment phase (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety, tolerability, and pharmacokinetics | pharmacokinetics and biomarker assessment during treatment phase (2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Placebo |
| Drug |
Placebo nasal spray twice daily for 2 weeks. |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |