E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate active Crohn disease |
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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 |
To determine if the study drug (Mesalazine EC tablets 500 mg) is at least as effective (non-inferiority testing) as the comparative medication (Salofalk® tablets 500 mg) in the common dose regimen 3× 3 tbl (= 4.5 g/daily) based on remission rate in both groups. |
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E.2.2 | Secondary objectives of the trial |
To determine the safety and tolerability of Mesalazine EC tablets 500 mg. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
To participate in this trial, patients will have to meet all of the following criteria: - established diagnosis of Crohn disease in Moderate active status verified by clinical evaluation, laboratory tests and by X-ray examination or/and colonoscopy and histology - Crohn disease of at least 3 months duration - acute exacerbation of moderate Crohn disease with a CDAI score between 220–400 points - patients between 18–75 years, both sexes - written informed consent obtained
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E.4 | Principal exclusion criteria |
Patients meeting any of the following criteria will be excluded from participation in this study: -positive stool culture for enteric pathogens including Salmonella, Shigella, Yersinia or Campylobacter -pregnant or lactating women -women of child bearing potential not taking adequate contraceptive precautions -maintenance treatment with higher daily doses (orally or rectally) than 4 g of Sulfasalazine or 2 g of Mesalazine EC 500 mg or any derivative up to one month before entering the study -chronic use of any anti-inflammatory drugs, including NSAID´s (rectally or orally) within 7 days prior to inclusion; chronic use is defined as intake of medication every day for more than 7 consecutive days -chronic administration of any steroids is an exclusion criterion within 7 days before entering the study -chronic administration of any immunosuppressive agents is an exclusion criterion within 3 months before entering the study -any other disease or condition which may interfere with study assessments as judged by the investigator -alcohol or drug abuse
-patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months -patients allergic to aspirin or other salicylates -clinically significant renal/hepatic impairment or serious heartdisease -patients presenting any malignant disease -patients likely not to comply with the study procedures -patients with any kind of stomy and after subtotal colectomy and with ileorectal anastomosis
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportions of patients considered to have achieved clinical remission (final CDAI score < 150 points). |
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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) | Yes |
E.8.2.2 | Placebo | No |
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 | 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 trial will be ended after the last visit of the last patient,when at least 396 evaluable patients in 20 centres (15 in the Czech Republic, 5 in the Slovak Republic) will be available. The total number of enrolled patients should be 436 patients in order to obtain 396 evaluable patients with the completed period of the treatment. The study treatment period is 12 weeks per patient. The trial could be also stopped according to protocol after the interim analysis. |
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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 | 6 |
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 |