Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Study P04849AM4)

Condition(s) targeted: Chronic Idiopathic Urticaria

Intervention: 5-mg Desloratadine (Drug); 10-mg Desloratadine (Drug); 20-mg Desloratadine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Schering-Plough

Official(s) and/or principal investigator(s):
Marcus Maurer, MD, Principal Investigator, Affiliation: Dpt. of Dermatology and Allergy, Allergie-Centrum-Charité/ECARF, Charité - Universitätsmedizin Berlin

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.

Official title: 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)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The change of the Urticaria Activity Score (UAS) from baseline at the primary time point in the final/terminal week (week 4) of the "Dose-Response Treatment Period." The primary comparison is between the 20-mg and 5-mg groups.

Secondary outcome:

UAS scores (and percent change from baseline of the UAS) for each week. Proportion of "responders" for each week and at the end of the "Dose-Response Treatment Period" (DRTP).

Proportion of "responders" for each week and at the end of the "Dose-Response Treatment Period".

Changes from baseline (baseline is AM and PM scores during the Baseline Week) at the end of each week and at the end of the "Dose-Response Treatment Period"; AM and PM pruritus scores; AM and PM number of hives/wheals

Response ratings to the single-item questions of interference with sleep and interference with activities of daily living; daily diary recordings.

Changes from baseline (Visit 2): ESS scores, DLQI scores, MOS-SS scores [SLPI I (6-items), SLPI II (9-items), S Disturbance Scale, S Adequacy Scale, Daytime Somnolence Scale]

Changes in Overall Condition of CIU at Visit 3 from baseline at Visit 2.

Global Therapeutic Response of CIU at Visit 3.

Proportion of subjects who were discontinued from the study during Baseline Week and "Dose-Response Treatment Period" due to an increase in disease severity and discontinued from the study prematurely as determined by the investigator.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must satisfy the following criteria before being enrolled/randomized into the

study.

- Subject must demonstrate willingness to participate in the study.

- Subject must be 18 to 75 years of age, of either gender, and any race.

- 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

- Subject's current episode of urticaria is sufficiently symptomatic at the Screening

Visit to qualify for this study, in the opinion of the investigator.

- Subject has a Baseline Week (entry period) UAS between 10 and 30 inclusive.

- Patient must understand and be willing to assess and record symptom scores.

- Has voluntarily signed a written informed consent.

- Subjects must confirm that all prior medication washout times have been observed.

- 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. Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, ie, double-barrier method (eg, male or female condom and spermicide), oral contraceptive, Depo-Provera, NuvaRing, contraceptive transdermal patch, etc, for female subjects of childbearing potential prior to screening and during the study. Women of childbearing potential should be counseled in the appropriate use of birth control while in the study. Vasectomy or tubal ligation is considered a single barrier. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods if they become sexually active while participating in the study.

- If subject is a female volunteer of childbearing potential, she must have a negative

urine pregnancy test at Screening/Visit 1.

- Subjects must be free of any clinically relevant disease other than chronic idiopathic

urticaria (CIU) that would, in the principal investigator's and/or sponsor's opinion, interfere with the conduct of the study or study evaluations.

- Subjects must be able to adhere to the dosing and visit schedules and agree to record

symptom severity scores, medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary.

Exclusion Criteria:

- Is a female who is pregnant, or intends to become pregnant during the study.

- Is nursing, or intends to be nursing during the study or within 90 days after study

completion.

- Has not observed the designated washout periods for any of the prohibited medications

outlined in Section 6. 2.

- Has used any investigational product within 30 days prior to enrollment.

- Have any of the following clinical conditions:

- Symptomatic seasonal or perennial allergic rhinitis.

- Asthma not controlled by short-acting beta-2 agonists used as necessary.

- The presence of permanent severe diseases, especially those affecting the immune

system, except urticaria.

- The presence of a permanent gastrointestinal condition which may influence the

oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).

- History of/or presence of epilepsy, significant neurological disorders,

cerebrovascular attacks or ischemia.

- History of/or presence of myocardial infarction or cardiac arrhythmia which

requires drug therapy.

- Evidence of/or a history of significant renal disease.

- Evidence of/or a history of significant hepatic disease.

- Presence of cancer which requires chemotherapy or radiation therapy.

- Presence of glaucoma.

- Presence of urinary bladder neck obstruction with emptying difficulties.

- Presence of acute urticaria .

- BMI > 35

- Has any clinically significant deviation from the appropriate reference range in the

physical examination, or other clinical evaluation that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.

- Is in a situation or condition that, in the opinion of the investigator, may interfere

with optimal participation in the study.

- Is participating in any other clinical study(ies).

- Is on the staff, affiliated with, or a family member of the staff personnel directly

involved with this study.

- Is allergic to or has a history of hypersensitivity to the study drug (desloratadine),

to any of its excipients, or to loratadine.

- Has the rare hereditary problem of galactose intolerance, the Lapp lactase deficiency,

or glucose-galactose malabsorption.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 2, Martigues 13500, France; Recruiting

Investigational Site 26, Bonn 53105, Germany; Recruiting

Investigational Site 27, Muenchen 80337, Germany; Completed

Investigational Site 34, Mainz 55131, Germany; Recruiting

Investigational Site 10, Thessaloniki, Greece; Recruiting

Investigational Site 54, Modena 41100, Italy; Recruiting

Investigational Site 58, Napoli 80131, Italy; Recruiting

Investigational Site 60, Siena 53100, Italy; Recruiting

Investigational Site 61, Genova 16132, Italy; Recruiting

Investigational Site 56, Firenze 50129, Italy; Recruiting

Investigational Site 59, Perugia 06122, Italy; Recruiting

Investigational Site 24, Oslo 0165, Norway; Recruiting

Investigational Site 29, Trondheim 7010, Norway; Recruiting

Investigational Site 32, Straume 5353, Norway; Recruiting

Investigational Site 13, Cluj, Romania; Recruiting

Investigational Site 39, Orebro, Sweden; Completed

Investigational Site 40, Stockholm 17176, Sweden; Recruiting

Investigational Site 41, Karlskoga, Sweden; Recruiting

Investigational Site 43, Linkoping SE-581 85, Sweden; Completed

Investigational Site 44, Lindesberg, Sweden; Completed

Investigational Site 38, Istanbul, Turkey; Recruiting

Investigational Site 35, Ankara, Turkey; Recruiting

Investigational Site 36, Izmir, Turkey; Recruiting

Investigational Site 37, Izmir, Turkey; Recruiting

Investigational Site 68, Ankara, Turkey; Recruiting

Starting date: September 2007
Ending date: March 2009
Last updated: October 21, 2008