A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
NCT ID: NCT00291642
Last Updated: 2018-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
551 participants
INTERVENTIONAL
2006-01-01
2006-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo (PBO)
A single dose of placebo was administered orally on Day 1.
Placebo drops
* Pharmaceutical form: Drops for oral administration
* Route of administration: Oral use
Placebo tablets matching to levocetirizine
* Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use
Placebo tablets matching to cetirizine
* Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use
Levocetirizine (LCTZ) 2.5 mg
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
Levocetirizine drops
* Pharmaceutical form: Drops for oral administration
* Concentration: 5 mg/ml
* Route of administration: Oral use
Levocetirizine (LCTZ) 5 mg
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
Levocetirizine tablets
* Pharmaceutical form: Tablets for oral administration
* Concentration: 5 mg
* Route of administration: Oral use
Cetirizine (CTZ) 5 mg
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
Cetirizine drops
* Pharmaceutical form: Drops for oral administration
* Concentration: 10 mg/ml
* Route of administration: Oral use
Cetirizine (CTZ) 10 mg
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Cetirizine tablets
* Pharmaceutical form: Tablets for oral administration
* Concentration: 10 mg
* Route of administration: Oral use
Interventions
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Placebo drops
* Pharmaceutical form: Drops for oral administration
* Route of administration: Oral use
Placebo tablets matching to levocetirizine
* Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use
Placebo tablets matching to cetirizine
* Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use
Levocetirizine drops
* Pharmaceutical form: Drops for oral administration
* Concentration: 5 mg/ml
* Route of administration: Oral use
Levocetirizine tablets
* Pharmaceutical form: Tablets for oral administration
* Concentration: 5 mg
* Route of administration: Oral use
Cetirizine drops
* Pharmaceutical form: Drops for oral administration
* Concentration: 10 mg/ml
* Route of administration: Oral use
Cetirizine tablets
* Pharmaceutical form: Tablets for oral administration
* Concentration: 10 mg
* Route of administration: Oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol
Exclusion Criteria
* Have used forbidden concomitant medications as defined by the protocol
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB (+1 844 599 2273)
Locations
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Kingston, Ontario, Canada
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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A00412
Identifier Type: -
Identifier Source: org_study_id
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