Trials / Completed
CompletedNCT00628108
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 6 Months – 11 Months
- Healthy volunteers
- Not accepted
Summary
To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levocetirizine 1.25 mg | Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks |
| OTHER | Placebo | Placebo oral liquid once a day for two weeks |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2008-03-04
- Last updated
- 2015-03-06
- Results posted
- 2009-10-14
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00628108. Inclusion in this directory is not an endorsement.