Phase 3
N=608
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01918033 ↗Enrolled (actual)
608
Serious AEs
0.2%
Results posted
Aug 2014
Primary outcome: Primary: Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 — -1.96; -1.94; -1.87 Score on a Scale — p=0.661
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desloratadine 5 mg (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 |
-1.96; -1.94; -1.87 | 0.661 |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) |
27; 29; 20 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to an AE |
1; 0; 2 | — |
| SECONDARY Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 |
-1.12; -1.11; -0.63; -1.39; -1.39; -1.48 | 0.010 sig |
| SECONDARY Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator |
-0.21; -0.29; -0.13; -0.27; -0.36; -0.38 | 0.547 |
| SECONDARY Change From Baseline in Nasal Finding Score Assessed by the Investigator |
-0.23; -0.17; -0.13; -0.35; -0.31; -0.34 | 0.376 |
| SECONDARY Change From Baseline in Eye Symptom Score Assessed by the Investigator |
-0.17; -0.24; -0.13; -0.28; -0.35; -0.26 | 0.849 |
| SECONDARY Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator |
67; 61; 53; 72; 83; 91 | 0.340 |
| SECONDARY Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator |
-0.18; -0.19; -0.07; -0.22; -0.21; -0.20 | 0.705 |
| SECONDARY Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries |
-0.27; -0.32; -0.23; -0.38; -0.40; -0.30 | 0.175 |
| SECONDARY Change From Baseline in Eye Symptom Score Reported in Participant Diaries |
-0.28; -0.25; -0.20; -0.31; -0.33; -0.26 | 0.414 |
Summary
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with perennial allergic rhinitis
- Outpatient.
Exclusion Criteria
- Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)
- Coexisting infections or systemic mycosis for which there are no effective antibiotics
- Asthma complication under treatment
- Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed
- Vasomotor rhinitis or eosinophilic rhinitis
- Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug
- History of hypersensitivity to antihistamines or study drug
- Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months
- Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent
- Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
- History of malignancy or clinically important hematological disorder
- History of severe drug allergy (e.g., anaphylactoid reaction).
Data sourced from ClinicalTrials.gov (NCT01918033). 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.