E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms which either occur spontaneously or as a result of environmental physical stimuli. Urticaria is known to severely impair the quality of life of affected patients. Thus, the majority of patients requires high-dosed antihistaminic drugs. |
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MedDRA Classification |
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 the study is to show that DPMP (Ebastel®) compared to placebo is effective in protecting urticaria patients from the impairment of performance that results from the provocation of urticaria symptoms. Performance before and after provocation will be measured by a standardized and validated psychometric instrument (DAKT, Differential Attention Test). |
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E.2.2 | Secondary objectives of the trial |
Change in the ability to cope with pressure after provocation Vienna Determination Test (DT) which allows for the assessment of the exhaustion in mental speed tasks. Change in mood after provocation Changes in patients’ mood will be assessed using the Profile of Mood States (POMS). This test is constructed as a list of adjectives. The following scales are examined: 1) Depression-Dejection, 2) Anger-Hostility, 3) Vigor-Activity, 4) Fatigue-Inertia. Change in urticaria symptoms Urticaria symptoms will be assessed using scores for numbers and sizes of wheals and erythemas and intensity of pruritus respectively burning using a modified version of the urticaria-activity score of Greaves. Change in patients’ evaluation of urticaria activity Changes of symptoms as assessed by the patients will be determined using an even numbered Likert scale.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Outpatients with at least one of the following forms of physical urticaria for more than 6 weeks: 1) cold urticaria, 2) factitious dermographism. Urticarial symptoms must comprise wheal and itch. 2. History of beneficial effects of antihistaminic treatment. 3. History suggests association of performance impairment with increased disease activity. 4. Age between 18 and 70 years. 5. Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised. 6. Patients must be able and willing to assess and record symptom scores and to perform psychometric tests. 7. Voluntarily signed written informed consent.
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E.4 | Principal exclusion criteria |
1. The presence of permanent severe diseases, especially those affecting the immune system, except physical urticaria. 2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract). 3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia. 4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. 5. Evidence of severe renal dysfunction 6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value). 7. History of adverse reactions to DPMP. 8. Presence of QT changes 9. Intake of medicaments that could cause QT changes 10. Presence of active cancer which requires chemotherapy or radiation therapy. 11. Presence of acute urticaria. 12. History or presence of alcohol abuse or drug addiction. 13. Participation in any clinical trial within 4 weeks prior to enrolment. 14. Itch of other origin. 15. Intake of antihistamines or leukotriene modifiers within 7 days prior to the beginning of the study 16. Intake of oral corticosteroids within 14 days prior to the beginning of the study 17. Use of depot corticosteroids or chronic inhaled or systemic corticosteroids within 21 days before beginning of the study 18. Intake of drugs affecting psychomotoric functions or alertness (e.g. antidepressants, anxiolytics, benzodiazepines). 19. Intake of CYP3A4-inhibitors 20. Pregnancy or breast-feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
The main goal of the analysis is to test whether a single dose of 20 mg DPMP (Ebastel®) is effective in protecting urticaria patients from the impairment of performance that results from the provocation of urticaria symptoms. The primary efficacy parameter of the study is the change in test score values after provocation (DAKT). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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The end of the trial (end of visit 2) or premature discontinuation of the trial subject. |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |