Clinical trial NCT02320396: Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
Official title: A Phase III, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 449
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.

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.

Primary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy
timeFrame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
measure: Number of Participants Who Experience at Least One Adverse Event (AE)
timeFrame: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
measure: Number of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment
timeFrame: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment
measure: Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
timeFrame: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
measure: Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
timeFrame: Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment
measure: Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy
timeFrame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
measure: Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
timeFrame: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
measure: Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
timeFrame: Baseline, Day 8 to 13 (Week 2) of double-blind treatment
measure: Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy
timeFrame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
measure: Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy
timeFrame: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
measure: Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2
timeFrame: From Baseline to Week 2
measure: Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2
timeFrame: From Baseline to Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Okubo K, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with seasonal allergic rhinitis: A randomized controlled trial. Arerugi. 2016;32(11):863-876.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11