An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
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.
Timeline
- Start
- 2013-08-27
- Primary completion
- 2014-02-28
- Completion
- 2014-03-13
Outcome
Met primary endpoint
registry analysis (unspecified test); Desloratadine 5 mg vs Placebo; p <0.001; Difference in LS means -1.17 (95% CI -1.69 to -0.65); Constrained Longitudinal Data Analysis NCT01916967 ↗
registry analysis (unspecified test); Desloratadine 10 mg vs Placebo; p <0.001; Difference in LS means -1.13 (95% CI -1.66 to -0.61); Constrained Longitudinal Data Analysis NCT01916967 ↗
Publications
- Results 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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Desloratadine | Small molecule | 5 mg | Oral |
| Subject | Desloratadine | Small molecule | 10 mg | Oral |