A study of the efficacy, safety, and quality of life (QOL) in patients with chronic idiopathic urticaria dosed with AERIUS Tablets (5 mg, 10 mg, or 20 mg once daily). Estudio de la eficacia, seguridad y calidad de vida (cdv) en pacientes con urticaria crónica idiopática tratados con aerius comprimidos (5, 10 ó 20 mg) una vez al día - ACCE

Integrated Therapeutics Group Incorporated (ITGI)0 sites600 target enrollmentMarch 19, 2007

ConditionsSubjects with an active episode of chronic idiopathic urticaria (CIU) and are taking a second-generation antihistamine will be selected for the study. The urticaria activity score (UAS) must be between 10-30, inclusive, at the end of the baseline week (entry period).MedDRA version: 8.1 Level: LLT Classification code 10021247 Term: Idiopathic urticaria

DrugsAerius

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subjects with an active episode of chronic idiopathic urticaria (CIU) and are taking a second-generation antihistamine will be selected for the study. The urticaria activity score (UAS) must be between 10-30, inclusive, at the end of the baseline week (entry period).
Sponsor: Integrated Therapeutics Group Incorporated (ITGI)
Enrollment: 600
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 19, 2007

End Date

April 3, 2009

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Integrated Therapeutics Group Incorporated (ITGI)

Eligibility Criteria

Inclusion Criteria

•1\) Subject must demonstrate willingness to participate in the study.
•2\) Subject must be 18 to 75 years of age, of either gender, and any race.
•3\) Subject must have had this episode of chronic idiopathic urticaria for at least 6 weeks or more,and has been dosing with a 2nd generation AH” for 2 weeks or longer, and
•4\) Subject’s current episode of urticaria is sufficiently symptomatic at the Screening Visit to qualify for this study in the opinion of the investigator.
•5\) Subject has a Baseline Week (entry period) UAS between 10 and 30 inclusive.
•6\) Patient must understand and be willing to assess and record symptom scores.
•7\) Has voluntarily signed a written informed consent.
•8\) Subjects must confirm that all prior medication washout times have been observed.
•9\) Subject must confirm that he/she is practicing adequate contraception:
•Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol\-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for \>1 year (i.e., women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (e.g., hysterectomy or tubal ligation).

Exclusion Criteria

•1\) Is a female who is pregnant, or intends to become pregnant during the study.
•2\) Is nursing, or intends to be nursing during the study or within 90 days after study completion.
•3\) Has not observed the designated washout periods for any of the prohibited medications outlined in Section 6\.2\.
•4\) Has used any investigational product within 30 days prior to enrollment.
•5\) Have any of the following clinical conditions:
•(a) Symptomatic seasonal or perennial allergic rhinitis.
•(b) Asthma not controlled by short\-acting beta\-2 agonists used as necessary.
•(c) The presence of permanent severe diseases, especially those affecting the immune system, except urticaria.
•(d) The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).
•(e) History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.