E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderately active Crohn’s disease (200 < CDAI < 400) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
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 assess the efficacy of oral budesonide (9 mg/day) vs. oral mesalazine (4.5 g/day) in moderately active Crohn’s disease |
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E.2.2 | Secondary objectives of the trial |
to assess the efficacy of two dose regimens (9 mg od vs. 3 mg tid) of budesonide and to examine the safety (e.g., adverse events, lab parameters). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Signed informed consent · Man or woman between 18 and 70 years of age · Symptoms of Crohn´s disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria [endoscopy not older than 12 months or if older, then clinical signs (e.g. pain localization, pain intensity, blood in stool) and behaviour (according to Vienna classification) should be unchanged compared to former episodes] · Localisation of CD either in terminal ileum, ascending colon or ileocolitis · Active phase of disease (200 < CDAI < 400) · Negative pregnancy test at baseline visit week 0 in females of childbearing potential · Use of appropriate contraceptive methods for females of childbearing potential during treatment (e.g. hormonal contraception, intrauterine device [IUD]) |
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E.4 | Principal exclusion criteria |
· Known Crohn’s lesions in the upper GI-tract (up to and including the jejunum) with present symptoms · CD in the rectum currently present · Short bowel syndrome · Septic complications · Baseline stool positive for germs causing bowel disease · Hemorrhagic diathesis · Abscess, perforation or active fistulas · Ileostomy or colostomy · Resection of more than 50 cm of the ileum · Bowel surgery within the last 3 months · Immediate surgery required (e.g. major stenosis, serious bleeding, peritonitis, ileus) · Clinical signs of stricturing disease · Subileus within the last 6 months (subileus with inflammatory hint allowed) · Suspicion of ileus, subileus or corresponding symptomatology · Parenteral or tube feeding · Active peptic ulcer disease, local intestinal infection, or if careful medical monitoring is not ensured: asthma, diabetes mellitus, infection or cardiovascular disease. · Abnormal hepatic function or liver cirrhosis (ALT, AST or AP > 2 x ULN) · Abnormal renal function (e.g. serum Creatinine > 1,5 mg/dl) · Active malignancy or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible. · Treatment with immunosuppressants, cytostatics, 6-TG, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit · Treatment with anti-TNF-a therapy within 6 months before baseline visit · Conventional steroids (iv, po, rectal) within 2 weeks before the study · > 6 mg/d budesonide po or > 3 g/d mesalazine po within 2 weeks before the study · Patients known to be steroid-refractory or steroid-dependent from former CD episodes · Treatment of study disease with oral antibiotics (e.g., metronidazole) within the last 2 weeks · Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit except ≤ 350 mg/d or short-term acetylsalicylic acid (paracetamol is allowed) · Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile · Well-founded doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs · Existing or intended pregnancy or lactation · Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of remission, defined as CDAI ≤ 150 |
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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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
comparison of dose schedule |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | Yes |
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 last 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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 30 |