E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with active ulcerative colitis |
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E.1.1.1 | Medical condition in easily understood language |
Patients with active ulcerative colitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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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 |
The primary objective is to evaluate the efficacy of a 8-week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to study safety and tolerability in the form of adverse events and laboratory parameters.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent, 2. Men or women aged 18 to 75 years, 3. Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology, 4. Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings, 5. Clinical Activity Index (CAI) > 4 and ≤ 12 and Endoscopic Index (EI) ≥ 4, 6. Insufficient response or intolerance to a previous or current treatment with mesalazine -containing or -releasing drugs,
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E.4 | Principal exclusion criteria |
1. Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis, 2. Toxic megacolon or fulminant colitis, 3. Colon resection, 4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), 5. Malabsorption syndromes, 6. Celiac disease, 7. Bleeding hemorrhoids, 8. Active peptic ulcer disease 9. Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, 10. Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, psychiatric disorders or infection if careful medical monitoring is not ensured, 11. Any severe infectious disease (e.g., tuberculosis, AIDS), 12. Severe co-morbidity substantially reducing life expectancy, 13. History of colorectal cancer, 14. History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of clinical remission at final/withdrawal visit |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 8 weeks of treatment |
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E.5.2 | Secondary end point(s) |
• Rate of clinical improvement at final/withdrawal visit • Number of stools per week • Number of bloody stools per week • Number of days with urgency per week • Time to first resolution of clinical symptoms • Rate of endoscopic remission/improvement at final/withdrawal visit • Rate of histological remission/improvement at final/withdrawal visit • Course of faecal calprotectin
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Each visit, if not otherwise defined. |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |