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). - ACCE

Schering Plough Research Institute, A Division of Schering Corporation0 sites600 target enrollmentMay 18, 2007

Overview

Phase: Not Applicable
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: Schering Plough Research Institute, A Division of Schering Corporation
Enrollment: 600
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

May 18, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Schering Plough Research Institute, A Division of Schering Corporation

•Subjects must satisfy the following criteria before being enrolled/randomized into the study.
•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:

•A subject who meets any of the following exclusion criteria will be disqualified from participation in the study:
•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).