POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)
This study has been completed.
Sponsor:
UCB Pharma
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00160537
First received: September 8, 2005
Last updated: December 13, 2013
Last verified: September 2009
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Purpose
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Levocetirizine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen |
Resource links provided by NLM:
Further study details as provided by UCB Pharma:
Primary Outcome Measures:
- Subjects' satisfaction / dissatisfaction after the first week of treatment.
Secondary Outcome Measures:
- allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2005 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Clinical history of SAR known and treated since 2 years.
- Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year).
- Minimum mean T5SS of 8 during the baseline period.
Exclusion Criteria:
- Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
- Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160537
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160537
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00160537 History of Changes |
| Other Study ID Numbers: | A00391, EudraCT 2004-002971-18, POPULAR |
| Study First Received: | September 8, 2005 |
| Last Updated: | December 13, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by UCB Pharma:
|
Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion) POPULAR, Xyzal, Levocetirizine |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections |
Levocetirizine Histamine Agents Histamine Antagonists Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015