An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

Study Overview
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Brief Summary
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This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.

Official Title
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A Phase III Multicentre, Parallel-group, Randomized, Placebo-controlled, Double-blind Clinical Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Chronic Urticaria.

Conditions
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Urticaria

Intervention / Treatment
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* Drug: Desloratadine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic urticaria [rash (erythema, wheal) for more than 1 month without any known cause] Out-patient Exclusion Criteria: Stimulation-induced urticaria [physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)] Hypersensitivity to antihistamines or ingredients of a study drug

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desloratadine 5 mg<br>Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | Drug: Desloratadine<br>* Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks<br>Drug: Placebo<br>* Placebo tablets, given orally, once daily in the evening for 2 weeks<br>|
| Experimental: Desloratadine 10 mg<br>Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks | Drug: Desloratadine<br>* Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks<br>|
| Placebo Comparator: Placebo<br>Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks | Drug: Placebo<br>* Placebo tablets, given orally, once daily in the evening for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated. | Baseline Visit and Week 2 Visit | 
| Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. | Up to 4 weeks (Up to 2 weeks after last dose of study drug) | 
| Number of Participants Who Discontinued Study Drug Due to an AE | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit | 
| Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | 
| Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | 
| Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2 | The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | 
| Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | 
| Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | 
| Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated. | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit | 
| Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated. | Baseline Visit and Week 1 Visit, Week 2 Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urticaria, Skin Diseases, Vascular, Skin Diseases, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Cholinergic Antagonists, Cholinergic Agents, Neurotransmitter Agents, Histamine H1 Antagonists, Non-Sedating, Histamine H1 Antagonists, Histamine Antagonists, Histamine Agents