Estudio en fase III, doble ciego, randomizado, controlado con placebo, comparativo de la eficacia y seguridad de bilastina 20 mg una vez al día y levocetirizina 5 mg para el tratamiento de la urticaria crónica idiopática”.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.

Phase 1

• Conditions: Chronic Idiopathic Urticaria; MedDRA version: 8.1Level: LLTClassification code 10021247

• Registration Number: EUCTR2006-001245-33-ES
• Lead Sponsor: FAES FARMA S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-27
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Patients of either sex between 18 and 70 years of age.
• Patients with a documented history of chronic idiopathic urticaria for at least 6 weeks prior to entry in the study, characterized by erythematous skin wheals accompanied by itching, occurring regularly, at least 3 times per week.
• Subjects who have given their informed consent to participate in the study after having received information about the design, aims and potential risks that could result from the study and having been informed that they can refuse to take part in or withdraw from the study at any time.
• Patients with active chronic idiopathic urticaria in the week before randomization visit (D-7), and at the randomization visit (D0). Patients should have for at least 3 days (consecutive or not) a moderate score (> 2) for at least 2 of the following symptoms.
-Itching intensity 0 = Absent, 1 = Mild (not annoying), 2 = Moderate (little disruption of activity), 3 = Severe (intense with disruption of activity)
-Wheals number 0 = Absent, 1 = Some (< 10), 2 = Numerous (>10), 3 = Extensive areas of the body covered
-Maximum size of the wheals 0 = Absent, 1 = < 1’5 cm, 2 = > 1’5 cm y < 2’5 cm, 3 = = 2’5 cm
• Patients willing to attend the required visits scheduled in the protocol, and fill in the diary card provided.
Patients must undergo a medical examination to participate in the study, and it should be normal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria may not be enrolled in this study:
• Patients that suffered other kind of dermatological pathology that can interfere in the evaluation of the chronic idiopathic urticaria: (isolated hereditary angioedema, dermographism, physics urticaria, urticaria due to a medicine or food allergy, infectious urticaria, contact urticaria, urticaria caused by vasculitis and/or colagenosis, paraneoplasic urticaria, parasitary urticaria, urticaria related with thyroid pathology, eczema or athopic dermatitis.
• Patients who have a history of autoimmune disorders, Hodgkin’s disease, lymphoma, leukemia and generalized cancer.
• Patients who are taking or have taken any of the following medications prior to enrolment in the study and have not complied with the specified wash-out period: Note: These wash-out periods should refer to the randomisation date.
- Systemic or topical corticosteroids: 4 weeks.
- Antihistamines: Astemizole (6 weeks), loratadine and desloratadine (10 days), other systemic antihistamines (3 days).
- Anti-leukotrienes (3 days)
- Doxepine (10 days)
- Delayed-release corticosteroids (3 months).
- Ketotifen (2 weeks).
- Tricyclic antidepressants (1 week)
- Macrolides antibiotics and imidazolic antifungals (systemic)
- H2 antihistamines.
- Anticholinergics.
- Drugs with antihistamine properties (phenothiazine).
- Sodium chromoglycate, nedocromil. (2 weeks).
- and any other drug with sedating action, anxiolytics, hypnotics, opioids, neuroleptics.
For those treatments with no wash-out period in brackets, the interruption of the treatment at the randomization visit is allowed.
• Hypersensitivity to H1 antihistamines, benzimidazoles or lactose.
• Severe concomitant disease that could interfere with treatment response (hepatic, renal, cardiovascular), electrocardiographic abnormalities, arrhythmias, recent acute myocardial infarction or neoplastic diseases.
• Pregnant or breast-feeding women. Women who could potentially become pregnant must use an effective birth control method (oral contraceptives, intrauterine device, condom or diaphragm). The patient’s agreement to use it will be considered sufficient for participation in the study.
Before the randomization a urine pregnancy test will be conducted in women with childbearing potential.
• Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
• Patients with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study or patients unable to sign the informed consent form
• Patients unable to comply with the study requirements or unable to complete the patient diary and take the study treatment.
• Patients who have a known lack of response to H1-antihistamines.
• Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
• Patients whose health could be harmed by their participation in the study.
• Patients who are currently participating in or have participated in another clinical trial within the last three months.

Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the Sponsor (or its representative) on a case-by case basis prior to enrolling the subject. This must be documented by both the Sponsor and the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified