E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Idiopathic Urticaria |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7 |
E.1.2 | Level | 0 |
E.1.2 | Classification code | 10021247 |
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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 |
To evaluate the efficacy of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy and safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over six-week treatment period in comparison with placebo.
To evaluate the safety of rupatadine 10 and 20 mg for the treatment of CIU symptoms over four-week treatment period in comparison with placebo.
To assess the patient discomfort by using a VAS.
To assess the patient QoL by a specific questionnaire, the DLQI.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Man or woman aged between 12 and 65
Active CIU (score equal or higher than 2 labeled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU equal or higher than 6 labeled as moderate pruritus for these 3 days
Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Screening Visit.
12 lead ECG obtained at screening within acceptable limits
Patient who signed the informed consent form.
Women of childbearing potential should have a negative pregnancy test. |
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E.4 | Principal exclusion criteria |
CIU associated to some underlying disease.
Patient under any systemic or topical medication for CIU and/or an inferior wash-out period as stated in the protocol.
Patients with analytical values twice as high than the upper limit of normality in the following parameters: ALP, ALT, AST, GGT and creatinine, and 1,5 times higher for than the upper limit of normality for the CK.
Cholinergic urticaria.
Patient taking medication that is known to interact with CYP3A4 isozyme of cytochrome P450.
Urticaria due to known etiology.
Patient unresponder to antihistaminic treatment
Start an immunotherapy schedule or changes in immunotherapy schedule 6 months previously to V0.
Known hypersensitivity to the study drugs (or compounds structurally related to) and to any other component of the study drugs.
Kidney or hepatic failure.
Pregnant or lactating female
Patient with hereditary angioedema or isolated dermographism
Patient with any parasitic infestations enable to cause any urticaria like symptoms-signs.
Patient taking drugs strongly associated with torsade de pointes.
Patient under any other treatment that could lead to symptomatic relief of the urticaria symptoms. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point will be based on the daily subjective assessment of the severity of each symptom of CIU, as recorded by patients in their diaries.
Change in mean pruritus score (MPS) over the 4-week treatment period. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
E.8.2.3 | Other | No |
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.8.6 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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |