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

This study has been completed.
Information provided by:
UCB, Inc. Identifier:
First received: September 4, 2007
Last updated: December 13, 2013
Last verified: September 2009

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

Condition Intervention Phase
Drug: Levocetirizine dihydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Investigator rated T5SS (Total 5 symptom Score) over 2 weeks [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 67
Study Start Date: August 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00525278

Sponsors and Collaborators
UCB, Inc.
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided Identifier: NCT00525278     History of Changes
Other Study ID Numbers: A00348
Study First Received: September 4, 2007
Last Updated: December 13, 2013
Health Authority: China: Department of Health, Pharmaceuticals registration and Import/Export control section

Keywords provided by UCB, Inc.:
Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Tract Infections
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 16, 2014