The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria

NCT00346606 | Unknown Phase 4

• 1 other identifier: 187CL1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks. Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study. Primary end point: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment. Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.

Conditions

Chronic Idiopathic Urticaria; Urticaria

Keywords

Chronic Idiopathic Urticaria; Desloratadine; Denosin; Levocetirizine

Outcome Measures

Primary Outcomes (1)

• To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment

Secondary Outcomes (7)

• To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.

• To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).

• Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.

• AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.

• PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.

Interventions

Denosin® and Xyzal® DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject or deputy has read or been informed and signed the Informed Consent Agreement and the subject will be willing and able to participate in the study.
• The subject ≥ 12 years old.
• The subject with documented signs and symptoms of CIU for 6 weeks or more.
• The subject has to have a CIU flare for 3 weeks or more before screening, with urticarial lesions visible 3 days or more per week.
• The overall severities of CIU have to be at least mild to moderate at screening and baseline, subjects have to have at least mild to moderate pruritus, hives have to be apparent at screening, and subjects have intention to treatment.

You may not qualify if:

• The subject has received any histamine, corticosteroids, ketotifene, systemic antibiotics, nedocromil, sodium cromoglycate or thyroxin drug within 7 days preceding randomization.
• The subject has received any other investigational drug within one month preceding randomization.
• The subject has previous non-response to antihistamines.
• The subject has previous allergy or allergies of desloratadine or levocetirizine.
• The subject need for long-term corticosteroids treatment (including inhaled, oral and topical dosage).
• The subject has autoimmune diseases.
• The subject's urticaria is physical urticaria, cholinergic urticaria or angioedema.
• The subject is in the situation of pregnancy or breastfeeding.
• The subject has liver dysfunction (AST ≧ 3 times normal range; ALT ≧ 3 times normal range ) or renal dysfunction (Creatinine ≧ 3.0mg/dl ).
• The subject is unable to keep an accurate diary of disease symptoms.
• The subject has significant concomitant illness, which, in the opinion of the investigator, will interfere with the evaluation of the study medications.

Sponsors & Collaborators

• Lotus Pharmaceutical: lead

Study Sites (1)

Department of Dermatology National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jia-Yu Chu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leanne Chou

CONTACT

+886-2-27738816; Leanne@lotuspharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: January 1, 2006
• Last Updated: June 30, 2006

Record last verified: 2006-05

Locations

TW (1)