Trials / Completed
CompletedNCT01916967
An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 239 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-08-27
- Primary completion
- 2014-02-28
- Completion
- 2014-03-13
- First posted
- 2013-08-06
- Last updated
- 2024-06-18
- Results posted
- 2014-10-30
Source: ClinicalTrials.gov record NCT01916967. Inclusion in this directory is not an endorsement.