To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

• ClinicalTrials.gov Identifier: NCT00525278
• Recruitment Status: Completed
• First Posted: September 5, 2007
• Last Update Posted: December 16, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Tracking Information

• First Submitted Date: September 4, 2007
• First Posted Date: September 5, 2007
• Last Update Posted Date: December 16, 2013
• Study Start Date: August 2003
• Actual Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 4, 2007): Investigator rated T5SS (Total 5 symptom Score) over 2 weeks [ Time Frame: 2 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 4, 2007): Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI). [ Time Frame: 2 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
• Official Title: Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR)
• Brief Summary: To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment

Condition

• Rhinitis
• Allergic
• Seasonal

• Intervention: Drug: Levocetirizine dihydrochloride
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 4, 2007): 67
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2003
• Actual Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female, 18 to 60 years old, inclusive
• two-year history of allergic rhinitis due to tree, grass or weed pollen
• sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

Exclusion Criteria:

• An ear, nose or throat (ENT) infection
• asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
• atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
• an associated ENT disease
• use of decongestants
• nasal or ocular topical treatment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00525278
• Other Study ID Numbers: A00348
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: UCB Pharma
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

• PRS Account: UCB Pharma
• Verification Date: September 2009