E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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).
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021247 |
E.1.2 | Term | Idiopathic urticaria |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to compare the effects of desloratadine 20 mg daily with desloratadine 5 mg daily in subjects with chronic idiopathic urticaria. The primary effect variable is the change in the UAS from baseline (Baseline Week - entry period). The primary time point is the final/terminal week of the “Dose-Response Treatment Period”.
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E.2.2 | Secondary objectives of the trial |
To compare the effects on the UAS changes at the final week of and weekly during the Dose-Response Treatment Period (DRTP) from baseline (Baseline Week) of DL 10 mg vs DL 5 mg daily and DL 20 mg vs DL 10 mg daily in patients with CIU. To compare the percent of responders for each week during the DRTP in each treatment group. To compare the changes at the end of the DRTP (Visit 3) from baseline visit (Visit 2) in the DLQI, ESS, MOS-SS, and Overall Condition of CIU, and responses to the questions about interference with sleep and activities of daily living. To evaluate the patients' assessment of Global Therapeutic Response at Visit 3. To determine the proportion of patients who discontinued from the study. Subgroup analyses based on the prior antihistamine medication will be analyzed for the efficacy variables. Safety information will be collected from the diaries and at each visit.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). 10) If subject is a female volunteer of childbearing potential, she must have a negative urine pregnancy test at Screening/Visit 1. 11) 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. 12) 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.
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E.4 | Principal 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. (f) History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. (g) Evidence of a history of significant renal disease. (h) Evidence of a history of significant hepatic disease. (i) Presence of cancer which requires chemotherapy or radiation therapy. (j) Presence of glaucoma. (k) Presence of urinary bladder neck obstruction with emptying difficulties. (l) Presence of acute urticaria .
(m) BMI > 35 6) 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. 7) Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study. 8) Is participating in any other clinical study(ies). 9) Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. 10) Is allergic to or has sensitivity to the study drug or its excipients.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint(s) for the study is change of the UAS from baseline, that is, the UAS at the end of the Baseline Week (entry period). The primary time point is the final/terminal week (week 4) of the “Dose-Response Treatment Period.” The primary comparison is between the 20 mg and 5 mg groups.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last case in the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |