Clinical trial NCT01916967: An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urticaria
Keywords: 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
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 239
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2
timeFrame: Baseline Visit and Week 2 Visit
measure: Number of Participants Who Experienced 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 Discontinued Study Drug Due to an AE
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit
measure: Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
measure: Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
measure: 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
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
measure: Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
measure: Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
measure: Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2
timeFrame: Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2
timeFrame: Baseline Visit and Week 1 Visit, Week 2 Visit
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hide M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with chronic urticaria: A randomized controlled trial. J Clin Therapeut Med. 2016;32(11):891-903.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11