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Completed

NCT Number: NCT00421109

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

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Key information

Conditions

Urticaria Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Erythema Graft vs Host Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre nº 101, Buenos Aires, Argentina

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About this study

A total of 540 patients with CIU will be enrolled in this pivotal, randomised, multicentre, international, double-blind, placebo and active-comparator controlled, parallel study . Patients will be selected from both public and private clinical practices. The study population includes males and females between 18 and 70 years of age, suffering from CIU for at least 6 weeks prior to entry in the study with no identifiable cause.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 70 years old.
  • Documented history of CIU for at least 6 weeks prior to entry in the study.

Exclusion criteria

  • Dermatological pathology other than chronic idiopathic urticaria.
  • History of autoimmune disorders, Hodgkin's disease, lymphoma, leukemia and generalized cancer.
  • Pregnant or breast-feeding women.
  • Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
  • Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
  • Patients who are currently participating in or have participated in another clinical trial within the last 3 months

Treatment and study plan

Bilastine

Drug

Encapsulated 20 mg Tablet. Once daily for 28 days

Levocetirizine

Drug

Encapsulated 5 mg tablet. Once daily for 28 days

Other names: Xyzall

Placebo

Drug

Encapsulated tablet. Once daily for 28 days

Primary outcomes

  1. Change from baseline, in the am/pm Total Symptom Score (TSS3), over the 28 days of the treatment period according to the patient's assessment in the diary card. (Reflective Symptoms)

    Time frame: 28 days

Secondary outcomes

  1. Reflective and Instantaneous symptoms scores.

    Time frame: 28 days

  2. QoL questionnaire.

    Time frame: 28 days

  3. Overall assessment of discomfort caused by CIU.

    Time frame: 28 days

  4. Investigator's overall clinical impression.

    Time frame: End of study

  5. Assessment of the Impact of urticaria on the sleep scale.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Faes Farma, S.A.

Industry

Registry information

Official study title

Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 11, 2007
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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