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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01916967
First received: August 2, 2013
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Urticaria
Drug: Desloratadine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 [ Time Frame: Baseline Visit and Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 4 weeks (Up to 2 weeks after last dose of study drug) ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Who Discontinued Study Drug Due to an AE [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 [ Time Frame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 [ Time Frame: Baseline Visit and Week 1 Visit, Week 2 Visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 239
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desloratadine 5 mg
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
Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks
Drug: Placebo
Placebo tablets, given orally, once daily in the evening for 2 weeks
Experimental: Desloratadine 10 mg
Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
Drug: Desloratadine
Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks
Placebo Comparator: Placebo
Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
Drug: Placebo
Placebo tablets, given orally, once daily in the evening for 2 weeks

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916967

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01916967     History of Changes
Other Study ID Numbers: 4117-201
Study First Received: August 2, 2013
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
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

Additional relevant MeSH terms:
Urticaria
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular
Desloratadine
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Cholinergic Agents
Cholinergic Antagonists
Histamine Agents
Histamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014