Phase 3
Completed N=239
An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
Source: ClinicalTrials.gov NCT01916967 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 — -3.19; -3.16; -2.02 Score on a Scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 |
-3.19; -3.16; -2.02 | <0.001 sig |
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event (AE) |
24; 18; 16; 0 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
0; 0; 2; 0 | — |
| SECONDARY Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 |
-2.57; -2.75; -0.80; -3.01; -3.16; -1.39 | — |
| SECONDARY Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 |
-2.62; -2.72; -0.61; -2.98; -3.13; -1.38 | — |
| SECONDARY Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 |
-2.31; -2.61; -0.99; -2.65; -2.98; -1.44 | — |
| SECONDARY 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 |
54; 55; 15; 54; 58; 32 | — |
| SECONDARY Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 |
-2.37; -2.73; -0.50; -2.53; -2.85; -1.27 | — |
| SECONDARY Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 |
-35.94; -39.60; -5.22; -40.82; -48.82; -15.88 | — |
| SECONDARY Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 |
-2.21; -2.31; -0.77; -2.15; -2.43; -1.17 | — |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 |
-3.82; -4.08; -1.60; -4.10; -4.01; -2.53 | — |
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
Data sourced from ClinicalTrials.gov (NCT01916967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.