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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Lotus Pharmaceutical.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lotus Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00346606
First received: June 29, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Idiopathic Urticaria
Urticaria
Drug: Denosin® and Xyzal®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lotus Pharmaceutical:

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.

Estimated Enrollment: 60
Study Start Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00346606

Contacts
Contact: Leanne Chou +886-2-27738816 ext 313 Leanne@lotuspharm.com

Locations
Taiwan
Department of Dermatology National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Jia-Yu Chu    +886-2-23123456 ext 5734      
Principal Investigator: Jia-Yu Chu         
Sponsors and Collaborators
Lotus Pharmaceutical
Investigators
Principal Investigator: Jia-Yu Chu National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346606     History of Changes
Other Study ID Numbers: 187CL1
Study First Received: June 29, 2006
Last Updated: June 29, 2006
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Lotus Pharmaceutical:
Chronic Idiopathic Urticaria
Desloratadine
Denosin
Levocetirizine

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Levocetirizine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on October 01, 2014