E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6 |
E.1.2 | Level | high |
E.1.2 | Classification code | 10011401 |
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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 efficacy of BDP 15 mg die (for 2 weeks) and 10 mg die (for 22 weeks), in comparison with placebo, in patients with Crohn’s Disease in maintaining the remission induced by a course of systemic steroids verifying the relapse rate. |
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E.2.2 | Secondary objectives of the trial |
To compare the tolerability of the two treatments by means of laboratory test, and evaluating the occurrence of Adverse Events. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Written informed consent; male or female of at least 18 year old; clinical diagnosis of active Crohn’s disease defined by a Crohn’s Disease Activity Index (CDAI) between 180 and 400; Active Crohn’s disease confined mainly to the distal ileum, ileocecal region, and/or ascending colon as verified by colonscopy or x-rays during at least 24 months before randomisation. Study medication compliance 80 % during the run-in period
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E.4 | Principal exclusion criteria |
Patients with any major manifestation of Active Crohn’s disease in the colon (except rare aphtae), rectum, and perianal Crohn disease Patients with septic complications, abscesses, perforation or active fistulae Patients that have had ileostomy, resection of the ileum more then 100 cm, or who required immediate surgery Patients treated with antitumor necrosis factor in the 6 months before the start of the study Patients receiving steroids and other immunosuppressive drugs. Positive stools culture for enteric pathogenic ova or parasites or clostridium difficile toxin; Less than 80% compliance during run-in period; Treatment with total parenteral nutrition (TPN) and with total enteral nutrition (TEN) will be stopped within 3 weeks prior to screening; Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological endocrine, pulmonary, cardiac, neurological or cerebral disease; Clinically significant or unstable concurrent disease: uncontrolled diabetes, uncontrolled hyperthyroidism, significant renal impairment (serum creatinine > 1,5 mg/dl), significant hepatic impairment (AST or ALT twice the upper limit of the normal range), poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastro-intestinal (i.e. active peptic ulcer), neurological or haematological, autoimmune diseases Cancer or any chronic disease with prognosis < 2 years Pregnant and breast feeding women History of alcohol or drug abuse Allergy, sensitivity or intolerance to study drugs and/or study drugs formulations ingredients Patients that have received investigational new drugs within the last 12 weeks Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study Patients who have been previously enrolled in this study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point of the study is to compare the therapeutic efficacy of the two treatments by assessment of the following parameter: relapse rate, defined as a Crohn’s Disease Activity Index (CDAI) > 150 (6), with at least of 60 points over the value registered at randomisation. Time to relapse is the secondary efficacy criterion.
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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 | Yes |
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 | No |
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 | 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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |