Phase 3
Completed N=449
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
Source: ClinicalTrials.gov NCT02320396 ↗Enrolled (actual)
449
Serious AEs
0.2%
Results posted
May 2016
Primary outcomePrimary: Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy — -1.41; -0.59 units on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy |
-1.41; -0.59 | <0.001 sig |
| PRIMARY Number of Participants Who Experience at Least One Adverse Event (AE) |
19; 13 | — |
| PRIMARY Number of Participants Who Discontinue Study Drug Due to an AE |
2; 2 | — |
| SECONDARY Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment |
-1.19; -0.38; -1.69; -0.84 | <0.001 sig |
| SECONDARY Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) |
-0.39; -0.14; -0.34; -0.13; -0.02; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) |
-0.51; -0.27; -0.49; -0.24; -0.03; 0.06 | <0.001 sig |
| SECONDARY Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy |
-0.44; -0.20; -0.41; -0.18; -0.02; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) |
-0.34; -0.09; -0.17; -0.02; -0.34; -0.09 | <0.001 sig |
| SECONDARY Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) |
-0.56; -0.32; -0.26; -0.13; -0.56; -0.32 | <0.001 sig |
| SECONDARY Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy |
-0.44; -0.19; -0.21; -0.07; -0.44; -0.19 | <0.001 sig |
| SECONDARY Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy |
-0.23; -0.07; -0.34; -0.14; -0.28; -0.10 | <0.001 sig |
| SECONDARY Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 |
2.3; 3.1; 26.1; 17.9; 28.4; 21.0 | 0.071 |
| SECONDARY Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 |
5.9; 4.9; 30.6; 16.1; 36.5; 21.1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
- Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.
Exclusion Criteria
- Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
- Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
- Has asthma that is under treatment and/or uncontrolled
- Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
- Has vasomotor rhinitis or eosinophilic rhinitis
- Has a history of hypersensitivity to antihistamines or ingredients of study drug
- Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs [injectable]) or immunological drugs within 28 days prior to Visit 2
- Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
- Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
- Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
- Will receive nasal nebulizer therapy and/or thermotherapy during study period
- Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
- Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
- Has a history of severe drug allergy (e.g. anaphylactoid reaction)
- Is pregnant or lactating or may be pregnant
- Is planning a remote trip for more than 1 day during the Symptom Confirmation Period or for more than 2 days during the Treatment Period.
Data sourced from ClinicalTrials.gov (NCT02320396). 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.