Trials / Completed
CompletedNCT00619801
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 173 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levocetirizine | Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks |
| DRUG | Placebo | Placebo oral drops (5 drops) dosed twice a day for 2 weeks. |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2008-02-21
- Last updated
- 2015-03-06
- Results posted
- 2009-09-04
Locations
28 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00619801. Inclusion in this directory is not an endorsement.