Phase 3
Completed N=220
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
Source: ClinicalTrials.gov NCT01857063 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure — 1.17; 1.18 score on a scale — p=0.913
Summary
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure |
1.17; 1.18 | 0.913 |
| PRIMARY Percentage of Participants Who Experience at Least One Adverse Event |
10.2; 16.5 | — |
| SECONDARY Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure |
1.85; 1.86 | 0.953 |
| SECONDARY Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure |
0.68; 0.68 | 0.974 |
| SECONDARY Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure |
0.29; 0.32 | 0.182 |
| SECONDARY Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure |
0.20; 0.18 | 0.161 |
| SECONDARY Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room |
0.54; 0.59; 1.00; 1.07; 1.36; 1.31 | — |
| SECONDARY Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room |
0.86; 0.91; 1.55; 1.63; 2.11; 2.04 | — |
| SECONDARY Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room |
0.32; 0.33; 0.55; 0.56; 0.74; 0.73 | — |
| SECONDARY Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room |
0.13; 0.17; 0.27; 0.33; 0.39; 0.38 | — |
| SECONDARY Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room |
0.09; 0.09; 0.18; 0.18; 0.23; 0.20 | — |
Eligibility Criteria
Inclusion Criteria
- Weight: ≥ 25 kg
- Height: ≥ 125 cm
- Able to record symptoms in a diary
- Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]
- Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay
Exclusion Criteria
- Has nasal findings that would interfere with evaluating nasal congestion symptoms
- Past or present medical history of bronchial asthma
- Medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by JC pollen exposure
Data sourced from ClinicalTrials.gov (NCT01857063). 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. Informational only — not medical advice.