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

Primary Purpose

Chronic Idiopathic Urticaria, Urticaria

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Denosin® and Xyzal®
Sponsored by
Lotus Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Urticaria focused on measuring Chronic Idiopathic Urticaria, Desloratadine, Denosin, Levocetirizine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Department of Dermatology National Taiwan University HospitalRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.

Full Information

First Posted
June 29, 2006
Last Updated
June 29, 2006
Sponsor
Lotus Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00346606
Brief Title
The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
Official Title
A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Compare the Efficacy and Safety of Desloratadine 5mg (Denosin®) With Levocetirizine 5mg (Xyzal®) in the Treatment of Chronic Idiopathic Urticaria Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lotus Pharmaceutical

4. Oversight

5. Study Description

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.
Detailed Description
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 endpoint: 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. Primary endpoint: 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 Endpoints- 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. PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated. The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes. Therapeutic response will be evaluated at visit 3~5. Safety will be evaluated including vital signs are recorded at all visits, whereas sleep latency using Epworth Sleepiness Scale (ESS) questionnaire and Visual analogue Scale (VAS) are scored at visit 2~5. Stanford Sleepiness Scale (SSS) are scored according to the instructions of diary cards at all visits. All adverse events are recorded and graded for severity at visit 2~5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria, Urticaria
Keywords
Chronic Idiopathic Urticaria, Desloratadine, Denosin, Levocetirizine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Denosin® and Xyzal®
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.
Title
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).
Title
Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
Title
AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
Title
PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
Title
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
Title
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leanne Chou
Phone
+886-2-27738816
Ext
313
Email
Leanne@lotuspharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Yu Chu
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia-Yu Chu
Phone
+886-2-23123456
Ext
5734
First Name & Middle Initial & Last Name & Degree
Jia-Yu Chu

12. IPD Sharing Statement

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

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