- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320396
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
February 7, 2022 updated by: Organon and Co
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
449
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Desloratadine
After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period.
|
Desloratadine 5 mg tablets
|
PLACEBO_COMPARATOR: Placebo
After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
|
Placebo tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy
Time Frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
|
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary.
The TNSS was the sum of the 4 nasal symptom sub-scores.
TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms.
Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period).
Post-BL measurement was an average from Day 1 to Day 13 (2 week average).
Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
|
Number of Participants Who Experience at Least One Adverse Event (AE)
Time Frame: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
|
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
|
Up to 4 weeks (Up to 2 weeks after last dose of study drug)
|
Number of Participants Who Discontinue Study Drug Due to an AE
Time Frame: Up to 2 weeks
|
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
|
Up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment
Time Frame: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment
|
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary.
The TNSS was the sum of the 4 nasal symptom sub-scores.
TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms.
Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period).
Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13.
Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment
|
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
Time Frame: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
|
Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose).
Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms.
BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period).
Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
|
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
Time Frame: Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment
|
Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose).
Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms.
BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period).
Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13.
Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment
|
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy
Time Frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
|
Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose).
Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms.
BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period).
Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13.
Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
|
Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
Time Frame: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
|
Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]).
Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom.
The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported.
Baseline measurement was an average of scores for 3 days prior to treatment.
Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
|
Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
Time Frame: Baseline, Day 8 to 13 (Week 2) of double-blind treatment
|
Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]).
Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom.
The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported.
Baseline measurement was an average of scores for 3 days prior to treatment.
Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13.
Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 8 to 13 (Week 2) of double-blind treatment
|
Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy
Time Frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
|
Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]).
Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom.
The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported.
BL measurement was an average of scores for 3 days prior to treatment.
Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13.
Change from BL = Post BL measurement - BL measurement.
|
Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
|
Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy
Time Frame: 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
|
Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible.
Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities.
Baseline measurement was an average of scores for 3 days prior to treatment.
Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13.
Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13.
Change from BL = Post BL measurement - BL measurement.
|
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
|
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2
Time Frame: From Baseline to Week 2
|
The investigator assessed the participant's symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant's symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable.
The evaluation result and reason for judgment (if needed) was recorded in the participant's case report form.
The investigator's impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant's own impression at Week 2. The percentage of participants with assessments of "Better" and "Much better" graded by the investigator (Investigator's Impression Rate) was reported and analyzed using Odds Ratio analysis.
|
From Baseline to Week 2
|
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2
Time Frame: From Baseline to Week 2
|
The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable.
The percentage of participants with assessments of "Better" and "Much better" graded by the participant (Participant's Impression Rate) was reported and analyzed using Odds Ratio analysis.
|
From Baseline to Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 9, 2015
Primary Completion (ACTUAL)
April 27, 2015
Study Completion (ACTUAL)
April 27, 2015
Study Registration Dates
First Submitted
December 15, 2014
First Submitted That Met QC Criteria
December 15, 2014
First Posted (ESTIMATE)
December 19, 2014
Study Record Updates
Last Update Posted (ACTUAL)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Desloratadine
Other Study ID Numbers
- 4117-204
- 152861 (REGISTRY: JAPIC-CTI)
- MK-4117-204 (OTHER: Merck Registration Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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