Phase 2
N=53
An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00804687 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry — -0.682; -0.504; -0.550 square centimeter*hour (cm^2*h) — p=0.0602
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Other); JNJ-39220675 (Drug); Pseudoephedrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry |
-0.682; -0.504; -0.550 | 0.0602 |
| SECONDARY Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS) |
45.720; 36.536; 43.195 | 0.0003 sig |
| SECONDARY Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1 |
2.7; 1.4; 1.7; 3.5; 2.2; 3.4 | — |
| SECONDARY Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1 |
0.304; 0.294; 0.312; -0.054; -0.028; -0.035 | — |
Summary
The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and pseudoephedrine compared to placebo (medication with no active ingredients) in participants with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen, dust or animal hair).
Eligibility Criteria
Inclusion Criteria
- Participants must have a clinical history of seasonal allergic rhinitis with seasonal onset and offset of nasal allergy symptoms at least during each of the last two ragweed allergy seasons
- Participants must have documentation of a positive skin test within 12 months of Screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test (allergy tests performed by injecting allergy-causing substances underneath the skin to see if they cause a reaction) for ragweed allergen
- Female participants must not be pregnant, lactating or be able to become pregnant
- Male participants must consent to use a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed
- Participants with body mass index between 18 and 32 kilogram per square meter
Exclusion Criteria
- Participants with clinically significant physical findings of nasal anatomical deformities
- Participants with a history of risk factors for torsades de pointes (heart failure, hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT or QTc interval or an abnormal 12-lead electrocardiogram except for clinically non-significant bradycardia
- Participants with history of exposure to an investigational treatment within the 30 days before the Screening Visit, or has ever taken JNJ-39220675 previously
- Participants with a history of clinically significant allergies, especially known hypersensitivity or intolerance to any drug or known allergy to the study drug or any of the excipients of the formulation
- Participants with a history of severe respiratory infection or disorder, epilepsy or seizures, coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease, or history of a positive test for Human immuno-deficiency (HIV), Hepatitis B or Hepatitis C
Data sourced from ClinicalTrials.gov (NCT00804687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.